Opdivo Qvantig is the first and only subcutaneously administered PD-1 inhibitor1
Given over three- to five-minutes, Opdivo Qvantig demonstrated consistent efficacy and showed a comparable safety profile to intravenous Opdivo in the Phase 3 CheckMate-67T trial1,3
PRINCETON, NJ, USA I December 27, 2024 I Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) granted approval for Opdivo Qvantig™ (nivolumab and hyaluronidase-nvhy) injectionfor subcutaneous use, a combination product of nivolumabco-formulated with recombinant human hyaluronidase (rHuPH20), in most previously approved adult, solid tumor Opdivo indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy® (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib.1,2 The approval is based on the results from the Phase 3 randomized, open-label CheckMate-67T trial, which demonstrated non-inferior co-primary pharmacokinetic (PK) exposures, similar efficacy in overall response rate (ORR), and showed a comparable safety profile vs. intravenous (IV) Opdivo.1,3
“This approval of subcutaneous nivolumab gives our patients a new option that can deliver consistent efficacy and comparable safety expected from IV nivolumab, and offers a patient-centric treatment experience,” said Professor Dr. Saby George, MD, FACP, medical oncologist and director of network clinical trials at Roswell Park Comprehensive Cancer Center.1 “Opdivo Qvantig offers faster administration*, delivered in three to five minutes. It may allow patients, in consultation with their doctors, to choose another treatment method and the flexibility to receive treatment closer to home.”1,2
In the trial, noninferiority was demonstrated for the co-primary endpoints of time-averaged concentration over 28 days (Cavgd28) and minimum concentration at steady state (Cminss) of Opdivo Qvantig vs. IV Opdivo.1,3 The geometric mean ratios (GMRs) for Cavgd28 was 2.10 (90% CI: 2.00-2.20) and the GMR for Cminss was 1.77 (90% CI: 1.63-1.93).1 As a key powered secondary endpoint, the overall response rate (ORR) in the Opdivo Qvantig arm (n=248) was 24% (95% CI: 19-30) compared with 18% (95% CI: 14-24) in the IV Opdivo arm (n=247), showing that Opdivo Qvantig has similar efficacy compared to IV Opdivo.1
Subcutaneous administration may offer flexibility to receive treatment where it is best for patients and their providers, and may reduce steps required for preparation and time needed for administration.5,6,7,8,9,10 In the CM–67T trial, average administration time with Opdivo Qvantig was approximately five minutes, and most patients received all doses of the study medication without an injection interruption or dose delay.3 With this approval, Opdivo Qvantig is now the first and only subcutaneously administered PD-1 inhibitor, offering a faster delivery for patients to receive this immunotherapy treatment option in three to five minutes compared to 30-minute IV Opdivo.1,2
Opdivo and Opdivo Qvantig are associated with the following Warnings and Precautions: severe and fatal immune-mediated adverse reactions including pneumonitis, colitis, hepatitis and hepatotoxicity, endocrinopathies, nephritis with renal dysfunction, dermatologic adverse reactions, other immune-mediated adverse reactions; complications of allogeneic hematopoietic stem cell transplantation (HSCT); embryo-fetal toxicity; and increased mortality in patients with multiple myeloma when Opdivo or Opdivo Qvantig are added to a thalidomide analogue and dexamethasone, which is not recommended outside of controlled clinical trials. Opdivo is associated with infusion related reactions. Please see Important Safety Information below.
“At Bristol Myers Squibb, we are committed to helping patients in all aspects of their healthcare journey,” said Adam Lenkowsky, executive vice president and chief commercialization officer. “Over the last decade, Opdivo has evolved as an immunotherapy option used in many indications across tumor types.9 With this new option, we look forward to further helping cancer patients with an administration method that gives themfaster delivery.”1,2
“Receiving a cancer diagnosis can be frightening and stressful,” said Audrey Davis, LPC and Senior Director of Programs and Health Equity at the Cancer Support Community. “Having a treatment option that may offer patients flexibility to receive treatment outside of traditional hospital settings and reduce the administration time is important.7,8,9,10 It’s exciting to see these continued advancements with immunotherapy administration that may offer another choice for patients and caregivers navigating this difficult journey.”9
*Refers to the injection time and does not include other aspects of treatment; actual clinic time may vary.
About CheckMate-67T
CheckMate-67T was a Phase 3, randomized, open-label, noninferiority trial evaluating Opdivo Qvantig compared to intravenous (IV) Opdivo, in adult patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who received prior systemic therapy.1,3 A total of 495 patients were randomized to receive either Opdivo Qvantig (1,200 mg of nivolumab and 20,000 units of hyaluronidase) every 4 weeks subcutaneously (n = 248), or Opdivo 3 mg/kg every 2 weeks intravenously (n = 247).1 The coprimary endpoints were time-averaged concentration over 28 days (Cavgd28) and minimum concentration at steady state (Cminss).1,3 The key powered secondary endpoint was overall response rate, as assessed by blinded independent central review.2
Select Safety Profile from CheckMate-67T
Serious adverse reactions occurred in 28% of patients receiving Opdivo Qvantig (n=247).1 The most frequent serious adverse reactions reported in >1% of patients who received Opdivo Qvantig were pleural effusion (1.6%), pneumonitis (1.6%), hyperglycemia (1.2%), hyperkalemia (1.2%), hemorrhage (1.2%) and diarrhea (1.2%).1 The most common adverse reactions (≥10%) in patients treated with Opdivo Qvantig (n=247) were musculoskeletal pain (31%), fatigue (20%), pruritus (16%), rash (15%), hypothyroidism (12%), diarrhea (11%), cough (11%), and abdominal pain (10%). Fatal adverse reactions occurred in 3 (1.2%) patients who received Opdivo Qvantig; these included myocarditis, myositis, and colitis complications.1 Study therapy was discontinued in 10% of patients due to adverse reactions.1 The safety profile of Opdivo Qvantig was comparable with the safety profile of IV Opdivo.1
About Subcutaneous Administration
Subcutaneous administration is delivery of treatment beneath the skin and is an alternative to IV infusion.10 There are several potential benefits of subcutaneous administration: it may offer the flexibility to provide and receive treatment where it is best for the healthcare provider and patient, may impact infusion chair capacity, and may reduce time spent preparing and administering treatment.5,6,7,8,9,10 It may also simplify administering treatment for patients who have difficult-to-access veins or do not want a port.11 Subcutaneous treatment has the potential to be administered by a healthcare professional without site of care restrictions.9
INDICATIONS
OPDIVO QVANTIG™ (nivolumab and hyaluronidase), as monotherapy, is indicated for the first-line treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma (RCC), following treatment with intravenous nivolumab and ipilimumab combination therapy.
Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of renal cell carcinoma.
OPDIVO QVANTIG™ (nivolumab and hyaluronidase), in combination with cabozantinib, is indicated for the first- line treatment of adult patients with advanced renal cell carcinoma (RCC).
OPDIVO QVANTIG™ (nivolumab and hyaluronidase), as monotherapy, is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.
OPDIVO QVANTIG™ (nivolumab and hyaluronidase), as monotherapy, is indicated for the treatment of adult patients with unresectable or metastatic melanoma.
OPDIVO QVANTIG™ (nivolumab and hyaluronidase), as monotherapy, is indicated for the treatment of adult patients with unresectable or metastatic melanoma following treatment with intravenous nivolumab and ipilimumab combination therapy.
Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for treatment of unresectable or metastatic melanoma.
OPDIVO QVANTIG™ (nivolumab and hyaluronidase), as monotherapy, is indicated for the adjuvant treatment of adult patients with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma.
OPDIVO QVANTIG™ (nivolumab and hyaluronidase), in combination with platinum-doublet chemotherapy, is indicated as neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC).
OPDIVO QVANTIG™ (nivolumab and hyaluronidase), in combination with platinum-doublet chemotherapy, is indicated for the neoadjuvant treatment of adult patients with resectable (tumors >/=4 cm or node positive) non- small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements, followed by single-agent OPDIVO QVANTIG as monotherapy in the adjuvant setting after surgical resection.
OPDIVO QVANTIG ™ (nivolumab and hyaluronidase), as monotherapy, is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO QVANTIG.
Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of metastatic NSCLC.
OPDIVO QVANTIG™ (nivolumab and hyaluronidase), as monotherapy, is indicated for the treatment of adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.
OPDIVO QVANTIG™ (nivolumab and hyaluronidase), as monotherapy, is indicated for the adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC.
OPDIVO QVANTIG™ (nivolumab and hyaluronidase), in combination with cisplatin and gemcitabine, is indicated for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC).
OPDIVO QVANTIG™ (nivolumab and hyaluronidase), as monotherapy, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
OPDIVO QVANTIG™ (nivolumab and hyaluronidase), as monotherapy, is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy (CRT).
OPDIVO QVANTIG™ (nivolumab and hyaluronidase) in combination with fluoropyrimidine- and platinum- containing chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).
Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of patients with unresectable advanced or metastatic ESCC.
OPDIVO QVANTIG™ (nivolumab and hyaluronidase) as monotherapy, is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.
OPDIVO QVANTIG™ (nivolumab and hyaluronidase) in combination with fluoropyrimidine- and platinum- containing chemotherapy, is indicated for the treatment of adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.
Please see U.S. Full Prescribing Information for OPDIVO QVANTIG.
INDICATIONS
OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic melanoma.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic melanoma.
OPDIVO® is indicated for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma.
OPDIVO® (nivolumab), in combination with platinum-doublet chemotherapy, is indicated as neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC).
OPDIVO® (nivolumab) in combination with platinum-doublet chemotherapy, is indicated for neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements, followed by single-agent OPDIVO® as adjuvant treatment after surgery.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab) and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.
OPDIVO® (nivolumab) is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM).
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma (RCC).
OPDIVO® (nivolumab), in combination with cabozantinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).
OPDIVO® (nivolumab) is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.
OPDIVO® (nivolumab) is indicated for the treatment of adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.
OPDIVO® (nivolumab) is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
OPDIVO® (nivolumab), as a single agent, is indicated for the adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC.
OPDIVO® (nivolumab), in combination with cisplatin and gemcitabine, is indicated as first-line treatment for adult patients with unresectable or metastatic urothelial carcinoma.
OPDIVO® (nivolumab) is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.
OPDIVO® (nivolumab) is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy (CRT).
OPDIVO® (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).
OPDIVO® (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the treatment of adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.
Please see U.S. Full Prescribing Information for OPDIVO and YERVOY
Bristol Myers Squibb: Creating a Better Future for People with Cancer
Bristol Myers Squibb is inspired by a single vision — transforming patients’ lives through science. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine and, through innovative digital platforms, are turning data into insights that sharpen their focus. Deep understanding of causal human biology, cutting-edge capabilities and differentiated research platforms uniquely position the company to approach cancer from every angle.
Cancer can have a relentless grasp on many parts of a patient’s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. As a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future.
About Bristol Myers Squibb’s Patient Access Support
Bristol Myers Squibb remains committed to providing assistance so that cancer patients who need our medicines can access them and expedite time to therapy.
BMS Access Support®, the Bristol Myers Squibb patient access and reimbursement program, is designed to help appropriate patients initiate and maintain access to BMS medicines during their treatment journey. BMS Access Support offers benefit investigation, prior authorization assistance, as well as co-pay assistance for eligible, commercially insured patients. More information about our access and reimbursement support can be obtained by calling BMS Access Supportat 1-800-861-0048 or by visiting www.bmsaccesssupport.com.
About the Bristol Myers Squibb and Ono Pharmaceutical Collaboration
In 2011, through a collaboration agreement with Ono Pharmaceutical Co., Bristol Myers Squibb expanded its territorial rights to develop and commercialize Opdivo globally, except in Japan, South Korea and Taiwan, where Ono had retained all rights to the compound at the time. On July 23, 2014, Ono and Bristol Myers Squibb further expanded the companies’ strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies – as single agents and combination regimens – for patients with cancer in Japan, South Korea and Taiwan.
About Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, X, YouTube, Facebook and Instagram.
References
- Opdivo Qvantig Prescribing Information. Opdivo Qvantig U.S. Product Information. Last updated: December 2024. Princeton, NJ: Bristol Myers Squibb Company.
- Opdivo Prescribing Information. Opdivo U.S. Product Information. Last updated: October 2024. Princeton, NJ: Bristol Myers Squibb Company.
- Albiges L, Bourlon MT, Chacón M, et al. Subcutaneous versus intravenous nivolumab for renal cell carcinoma. Ann Oncol. 2024 Sep 15:S0923-7534(24)03996-6.
- Albiges L, Bourlon MT, Chacón M, et al. Subcutaneous versus intravenous nivolumab for renal cell carcinoma (Supplementary Data). Ann Oncol. 2024 Sep 15:S0923-7534(24)03996-6.
- De Cock E, Kritikou P, Sandoval M, et al. Time Savings with Rituximab Subcutaneous Injection versus Rituximab Intravenous Infusion: A Time and Motion Study in Eight Countries. PLoS One. 2016;11(6):e0157957.
- Lopez-Vivianco G, Salvador J, et al. Cost minimization analysis of treatment with intravenous or subcutaneous trastuzumab in patients with HER2-positive breast cancer in Spain. Clin Transl Oncol. 2017;19(12):1453-1461.
- Dent S, Ammndolea C, Christofides A, et al. A multidisciplinary perspective on the subcutaneous administration of trastuzumab in HER2-positive breast cancer. 2019;26(1):e70-e80.
- McCloskey C, Ortega MT, Nair S, et al. A Systematic Review of Time and Resource Use Costs of Subcutaneous Versus Intravenous Administration of Oncology Biologics in a Hospital Setting. Pharmacoecon Open. 2023;(7)1:3-36.
- Bittner B, Schmidt J. Advancing Subcutaneous Dosing Regimens for Biotherapeutics: Clinical Strategies for Expedited Market Access. BioDrugs. 2024:38(1):23-46.
- Burcombe R, Chan S, et al. Subcutaneous Trastuzumab (Herceptin®): A UK Time and Motion Study in Comparison with Intravenous Formulation for the Treatment of Patients with HER2-Positive Early Breast Cancer. Advances in Breast Cancer Research. 2012;2(4).
- MedlinePlus.gov. Subcutaneous (SQ) injections. Available at https://medlineplus.gov/ency/patientinstructions/000430.htm. Accessed November 25, 2024.
- Leveque D. Subcutaneous administration of anticancer agents. Anticancer Res. 2014;34(4):1579-1586.
SOURCE: Bristol Myers Squibb
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Opdivo Qvantig is the first and only subcutaneously administered PD-1 inhibitor1
Given over three- to five-minutes, Opdivo Qvantig demonstrated consistent efficacy and showed a comparable safety profile to intravenous Opdivo in the Phase 3 CheckMate-67T trial1,3
PRINCETON, NJ, USA I December 27, 2024 I Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) granted approval for Opdivo Qvantig™ (nivolumab and hyaluronidase-nvhy) injectionfor subcutaneous use, a combination product of nivolumabco-formulated with recombinant human hyaluronidase (rHuPH20), in most previously approved adult, solid tumor Opdivo indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy® (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib.1,2 The approval is based on the results from the Phase 3 randomized, open-label CheckMate-67T trial, which demonstrated non-inferior co-primary pharmacokinetic (PK) exposures, similar efficacy in overall response rate (ORR), and showed a comparable safety profile vs. intravenous (IV) Opdivo.1,3
“This approval of subcutaneous nivolumab gives our patients a new option that can deliver consistent efficacy and comparable safety expected from IV nivolumab, and offers a patient-centric treatment experience,” said Professor Dr. Saby George, MD, FACP, medical oncologist and director of network clinical trials at Roswell Park Comprehensive Cancer Center.1 “Opdivo Qvantig offers faster administration*, delivered in three to five minutes. It may allow patients, in consultation with their doctors, to choose another treatment method and the flexibility to receive treatment closer to home.”1,2
In the trial, noninferiority was demonstrated for the co-primary endpoints of time-averaged concentration over 28 days (Cavgd28) and minimum concentration at steady state (Cminss) of Opdivo Qvantig vs. IV Opdivo.1,3 The geometric mean ratios (GMRs) for Cavgd28 was 2.10 (90% CI: 2.00-2.20) and the GMR for Cminss was 1.77 (90% CI: 1.63-1.93).1 As a key powered secondary endpoint, the overall response rate (ORR) in the Opdivo Qvantig arm (n=248) was 24% (95% CI: 19-30) compared with 18% (95% CI: 14-24) in the IV Opdivo arm (n=247), showing that Opdivo Qvantig has similar efficacy compared to IV Opdivo.1
Subcutaneous administration may offer flexibility to receive treatment where it is best for patients and their providers, and may reduce steps required for preparation and time needed for administration.5,6,7,8,9,10 In the CM–67T trial, average administration time with Opdivo Qvantig was approximately five minutes, and most patients received all doses of the study medication without an injection interruption or dose delay.3 With this approval, Opdivo Qvantig is now the first and only subcutaneously administered PD-1 inhibitor, offering a faster delivery for patients to receive this immunotherapy treatment option in three to five minutes compared to 30-minute IV Opdivo.1,2
Opdivo and Opdivo Qvantig are associated with the following Warnings and Precautions: severe and fatal immune-mediated adverse reactions including pneumonitis, colitis, hepatitis and hepatotoxicity, endocrinopathies, nephritis with renal dysfunction, dermatologic adverse reactions, other immune-mediated adverse reactions; complications of allogeneic hematopoietic stem cell transplantation (HSCT); embryo-fetal toxicity; and increased mortality in patients with multiple myeloma when Opdivo or Opdivo Qvantig are added to a thalidomide analogue and dexamethasone, which is not recommended outside of controlled clinical trials. Opdivo is associated with infusion related reactions. Please see Important Safety Information below.
“At Bristol Myers Squibb, we are committed to helping patients in all aspects of their healthcare journey,” said Adam Lenkowsky, executive vice president and chief commercialization officer. “Over the last decade, Opdivo has evolved as an immunotherapy option used in many indications across tumor types.9 With this new option, we look forward to further helping cancer patients with an administration method that gives themfaster delivery.”1,2
“Receiving a cancer diagnosis can be frightening and stressful,” said Audrey Davis, LPC and Senior Director of Programs and Health Equity at the Cancer Support Community. “Having a treatment option that may offer patients flexibility to receive treatment outside of traditional hospital settings and reduce the administration time is important.7,8,9,10 It’s exciting to see these continued advancements with immunotherapy administration that may offer another choice for patients and caregivers navigating this difficult journey.”9
*Refers to the injection time and does not include other aspects of treatment; actual clinic time may vary.
About CheckMate-67T
CheckMate-67T was a Phase 3, randomized, open-label, noninferiority trial evaluating Opdivo Qvantig compared to intravenous (IV) Opdivo, in adult patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who received prior systemic therapy.1,3 A total of 495 patients were randomized to receive either Opdivo Qvantig (1,200 mg of nivolumab and 20,000 units of hyaluronidase) every 4 weeks subcutaneously (n = 248), or Opdivo 3 mg/kg every 2 weeks intravenously (n = 247).1 The coprimary endpoints were time-averaged concentration over 28 days (Cavgd28) and minimum concentration at steady state (Cminss).1,3 The key powered secondary endpoint was overall response rate, as assessed by blinded independent central review.2
Select Safety Profile from CheckMate-67T
Serious adverse reactions occurred in 28% of patients receiving Opdivo Qvantig (n=247).1 The most frequent serious adverse reactions reported in >1% of patients who received Opdivo Qvantig were pleural effusion (1.6%), pneumonitis (1.6%), hyperglycemia (1.2%), hyperkalemia (1.2%), hemorrhage (1.2%) and diarrhea (1.2%).1 The most common adverse reactions (≥10%) in patients treated with Opdivo Qvantig (n=247) were musculoskeletal pain (31%), fatigue (20%), pruritus (16%), rash (15%), hypothyroidism (12%), diarrhea (11%), cough (11%), and abdominal pain (10%). Fatal adverse reactions occurred in 3 (1.2%) patients who received Opdivo Qvantig; these included myocarditis, myositis, and colitis complications.1 Study therapy was discontinued in 10% of patients due to adverse reactions.1 The safety profile of Opdivo Qvantig was comparable with the safety profile of IV Opdivo.1
About Subcutaneous Administration
Subcutaneous administration is delivery of treatment beneath the skin and is an alternative to IV infusion.10 There are several potential benefits of subcutaneous administration: it may offer the flexibility to provide and receive treatment where it is best for the healthcare provider and patient, may impact infusion chair capacity, and may reduce time spent preparing and administering treatment.5,6,7,8,9,10 It may also simplify administering treatment for patients who have difficult-to-access veins or do not want a port.11 Subcutaneous treatment has the potential to be administered by a healthcare professional without site of care restrictions.9
INDICATIONS
OPDIVO QVANTIG™ (nivolumab and hyaluronidase), as monotherapy, is indicated for the first-line treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma (RCC), following treatment with intravenous nivolumab and ipilimumab combination therapy.
Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of renal cell carcinoma.
OPDIVO QVANTIG™ (nivolumab and hyaluronidase), in combination with cabozantinib, is indicated for the first- line treatment of adult patients with advanced renal cell carcinoma (RCC).
OPDIVO QVANTIG™ (nivolumab and hyaluronidase), as monotherapy, is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.
OPDIVO QVANTIG™ (nivolumab and hyaluronidase), as monotherapy, is indicated for the treatment of adult patients with unresectable or metastatic melanoma.
OPDIVO QVANTIG™ (nivolumab and hyaluronidase), as monotherapy, is indicated for the treatment of adult patients with unresectable or metastatic melanoma following treatment with intravenous nivolumab and ipilimumab combination therapy.
Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for treatment of unresectable or metastatic melanoma.
OPDIVO QVANTIG™ (nivolumab and hyaluronidase), as monotherapy, is indicated for the adjuvant treatment of adult patients with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma.
OPDIVO QVANTIG™ (nivolumab and hyaluronidase), in combination with platinum-doublet chemotherapy, is indicated as neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC).
OPDIVO QVANTIG™ (nivolumab and hyaluronidase), in combination with platinum-doublet chemotherapy, is indicated for the neoadjuvant treatment of adult patients with resectable (tumors >/=4 cm or node positive) non- small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements, followed by single-agent OPDIVO QVANTIG as monotherapy in the adjuvant setting after surgical resection.
OPDIVO QVANTIG ™ (nivolumab and hyaluronidase), as monotherapy, is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO QVANTIG.
Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of metastatic NSCLC.
OPDIVO QVANTIG™ (nivolumab and hyaluronidase), as monotherapy, is indicated for the treatment of adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.
OPDIVO QVANTIG™ (nivolumab and hyaluronidase), as monotherapy, is indicated for the adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC.
OPDIVO QVANTIG™ (nivolumab and hyaluronidase), in combination with cisplatin and gemcitabine, is indicated for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC).
OPDIVO QVANTIG™ (nivolumab and hyaluronidase), as monotherapy, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
OPDIVO QVANTIG™ (nivolumab and hyaluronidase), as monotherapy, is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy (CRT).
OPDIVO QVANTIG™ (nivolumab and hyaluronidase) in combination with fluoropyrimidine- and platinum- containing chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).
Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of patients with unresectable advanced or metastatic ESCC.
OPDIVO QVANTIG™ (nivolumab and hyaluronidase) as monotherapy, is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.
OPDIVO QVANTIG™ (nivolumab and hyaluronidase) in combination with fluoropyrimidine- and platinum- containing chemotherapy, is indicated for the treatment of adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.
Please see U.S. Full Prescribing Information for OPDIVO QVANTIG.
INDICATIONS
OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic melanoma.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic melanoma.
OPDIVO® is indicated for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma.
OPDIVO® (nivolumab), in combination with platinum-doublet chemotherapy, is indicated as neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC).
OPDIVO® (nivolumab) in combination with platinum-doublet chemotherapy, is indicated for neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements, followed by single-agent OPDIVO® as adjuvant treatment after surgery.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab) and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.
OPDIVO® (nivolumab) is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM).
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma (RCC).
OPDIVO® (nivolumab), in combination with cabozantinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).
OPDIVO® (nivolumab) is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.
OPDIVO® (nivolumab) is indicated for the treatment of adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.
OPDIVO® (nivolumab) is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
OPDIVO® (nivolumab), as a single agent, is indicated for the adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC.
OPDIVO® (nivolumab), in combination with cisplatin and gemcitabine, is indicated as first-line treatment for adult patients with unresectable or metastatic urothelial carcinoma.
OPDIVO® (nivolumab) is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.
OPDIVO® (nivolumab) is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy (CRT).
OPDIVO® (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).
OPDIVO® (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the treatment of adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.
Please see U.S. Full Prescribing Information for OPDIVO and YERVOY
Bristol Myers Squibb: Creating a Better Future for People with Cancer
Bristol Myers Squibb is inspired by a single vision — transforming patients’ lives through science. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine and, through innovative digital platforms, are turning data into insights that sharpen their focus. Deep understanding of causal human biology, cutting-edge capabilities and differentiated research platforms uniquely position the company to approach cancer from every angle.
Cancer can have a relentless grasp on many parts of a patient’s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. As a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future.
About Bristol Myers Squibb’s Patient Access Support
Bristol Myers Squibb remains committed to providing assistance so that cancer patients who need our medicines can access them and expedite time to therapy.
BMS Access Support®, the Bristol Myers Squibb patient access and reimbursement program, is designed to help appropriate patients initiate and maintain access to BMS medicines during their treatment journey. BMS Access Support offers benefit investigation, prior authorization assistance, as well as co-pay assistance for eligible, commercially insured patients. More information about our access and reimbursement support can be obtained by calling BMS Access Supportat 1-800-861-0048 or by visiting www.bmsaccesssupport.com.
About the Bristol Myers Squibb and Ono Pharmaceutical Collaboration
In 2011, through a collaboration agreement with Ono Pharmaceutical Co., Bristol Myers Squibb expanded its territorial rights to develop and commercialize Opdivo globally, except in Japan, South Korea and Taiwan, where Ono had retained all rights to the compound at the time. On July 23, 2014, Ono and Bristol Myers Squibb further expanded the companies’ strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies – as single agents and combination regimens – for patients with cancer in Japan, South Korea and Taiwan.
About Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, X, YouTube, Facebook and Instagram.
References
- Opdivo Qvantig Prescribing Information. Opdivo Qvantig U.S. Product Information. Last updated: December 2024. Princeton, NJ: Bristol Myers Squibb Company.
- Opdivo Prescribing Information. Opdivo U.S. Product Information. Last updated: October 2024. Princeton, NJ: Bristol Myers Squibb Company.
- Albiges L, Bourlon MT, Chacón M, et al. Subcutaneous versus intravenous nivolumab for renal cell carcinoma. Ann Oncol. 2024 Sep 15:S0923-7534(24)03996-6.
- Albiges L, Bourlon MT, Chacón M, et al. Subcutaneous versus intravenous nivolumab for renal cell carcinoma (Supplementary Data). Ann Oncol. 2024 Sep 15:S0923-7534(24)03996-6.
- De Cock E, Kritikou P, Sandoval M, et al. Time Savings with Rituximab Subcutaneous Injection versus Rituximab Intravenous Infusion: A Time and Motion Study in Eight Countries. PLoS One. 2016;11(6):e0157957.
- Lopez-Vivianco G, Salvador J, et al. Cost minimization analysis of treatment with intravenous or subcutaneous trastuzumab in patients with HER2-positive breast cancer in Spain. Clin Transl Oncol. 2017;19(12):1453-1461.
- Dent S, Ammndolea C, Christofides A, et al. A multidisciplinary perspective on the subcutaneous administration of trastuzumab in HER2-positive breast cancer. 2019;26(1):e70-e80.
- McCloskey C, Ortega MT, Nair S, et al. A Systematic Review of Time and Resource Use Costs of Subcutaneous Versus Intravenous Administration of Oncology Biologics in a Hospital Setting. Pharmacoecon Open. 2023;(7)1:3-36.
- Bittner B, Schmidt J. Advancing Subcutaneous Dosing Regimens for Biotherapeutics: Clinical Strategies for Expedited Market Access. BioDrugs. 2024:38(1):23-46.
- Burcombe R, Chan S, et al. Subcutaneous Trastuzumab (Herceptin®): A UK Time and Motion Study in Comparison with Intravenous Formulation for the Treatment of Patients with HER2-Positive Early Breast Cancer. Advances in Breast Cancer Research. 2012;2(4).
- MedlinePlus.gov. Subcutaneous (SQ) injections. Available at https://medlineplus.gov/ency/patientinstructions/000430.htm. Accessed November 25, 2024.
- Leveque D. Subcutaneous administration of anticancer agents. Anticancer Res. 2014;34(4):1579-1586.
SOURCE: Bristol Myers Squibb
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