– Launch of LOQTORZI offers first and only FDA-approved treatment for NPC in all lines of therapy –
– Indicated in combination with chemotherapy for 1st line treatment and as monotherapy for patients with disease progression on or after platinum containing chemotherapy, irrespective of PD-L1 status –
– LOQTORZI is now available for purchase through select specialty distributors –
REDWOOD CITY, CA, USA I January 02, 2024 I Coherus BioSciences, Inc. (“Coherus,” NASDAQ: CHRS) today announced that LOQTORZI™ (toripalimab-tpzi) is now available through select specialty distributors in the United States. LOQTORZI is indicated in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC), and as monotherapy for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy. LOQTORZI is a next-generation, programmed death receptor-1 (PD-1) monoclonal antibody that blocks PD-1 ligands PD-L1 and PD-L2 with high potency at a unique site on the PD-1 receptor, enabling the immune system to activate and kill the tumor.
“For people with rare cancers such as NPC, the prognosis is poor and treatment options have been limited,” said John Hopper, Founder of the Patient Activation Group, Co-Chair of the NORD Rare Cancer Coalition and board director of rare cancer foundation-SARC (Sarcoma Alliance for Research through Collaboration). “The availability of LOQTORZI as a new treatment option for advanced NPC represents a meaningful step forward for NPC patients and gives further hope to rare cancer advocates that there will be more options for rare cancer patients in the future.”
NPC affects approximately 2000 patients in the U.S. annually. Until now the standard of care was chemotherapy. In December, the NCCN committee classified LOQTORZI as a preferred category 1 treatment option in combination with gemcitabine and cisplatin. The decision was based on results of the JUPITER-02 Phase 3 study and the POLARIS-02 Phase 2 study. In the JUPITER-02 Phase 3 study, LOQTORZI combined with chemotherapy significantly improved progression-free survival (PFS), reducing the risk of disease progression or death by 48% compared to chemotherapy alone. LOQTORZI also demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS), with treatment resulting in a 37% reduction in the risk of death versus chemotherapy alone. In the POLARIS-02 clinical study, LOQTORZI demonstrated durable anti-tumor activity in patients with recurrent or metastatic NPC who failed previous chemotherapy, with an objective response rate (ORR) of 20.5%, a disease control rate (DCR) of 40.0%, and a median OS of 17.4 months with an acceptable safety profile.
“We are proud to bring LOQTORZI to a patient population that has had no FDA-approved options available, and our mission is to establish LOQTORZI plus chemotherapy as the new standard of care for relapsed/metastatic NPC. LOQTORZI has demonstrated impressive clinical benefits, including PFS and OS, offering R/M NPC patients new hope for extended survival,” said Paul Reider, Chief Commercial Officer of Coherus. “As the first and only FDA-approved treatment for this type of cancer, we’ll work tirelessly to support physician education and patient access, while activating the NPC patient community through our partnership with patient advocacy groups and our own NPCfacts.com community.”
“The launch of LOQTORZI is a foundational milestone, signaling Coherus’ emergence as a commercial-stage immuno-oncology company,” said Denny Lanfear, Chairman and Chief Executive Officer of Coherus. “We believe LOQTORZI will play a key role in next-generation novel immuno-oncology treatment combinations aimed at extending patient survival across multiple tumor types through our own internal pipeline as well as our external collaborations.”
LOQTORZI is commercially available for purchase through select specialty distributors including Cencora (formerly ABC), Cardinal and McKesson. Each carton contains one 240 mg/6 mL (40 mg/mL) single-dose vial. Contact Coherus BioSciences Customer Services at 1-844-562-6004 for more information. LOQTORZI Solutions™ for HCPs is now online and offers healthcare professionals comprehensive practice and patient support that includes extensive patient assistance and office resources to ensure successful access and reimbursement. Billing will occur under the medical benefit using an Unclassified HCPCS code J3490 or J3590 with a unique NDC number of 70114-0340-01. Coherus expects a product-specific, permanent J-code to be assigned to LOQTORZI in mid-2024.
About LOQTORZI Solutions™
Coherus is committed to supporting patients with programs for zero out-of-pocket costs or patient assistance for eligible patients so that they may benefit from a proven PD-1 immunotherapy, with less financial burden. Through LOQTORZI Solutions, our robust patient support services include reimbursement support, patient support, and access support. More specific product information can be found on LOQTORZI.com.
Commitment to the NPC community
Given the limited resources available to patients and caregivers contending with NPC, Coherus has launched a new educational community resource, NPCFacts.com, which includes detailed information about the types of NPC as well as its causes, diagnosis, and treatment options. Currently there are over 2000 patients and caregivers enrolled in this program and product education is underway.
In addition to education about nasopharyngeal carcinoma, the website includes links to patient advocacy organizations providing additional resources, including the Head and Neck Cancer Alliance, Support for People with Oral Head and Neck Cancer, and Thyroid Head and Neck Cancer Foundation. The website includes a companion website for healthcare professionals treating patients with NPC, including educational resources and opportunities for peer-to-peer education.
About NPC
NPC is a type of aggressive cancer that starts in the nasopharynx, the upper part of the throat behind the nose and near the base of the skull. NPC is rare in the United States, with an annual incidence of fewer than one per 100,000. The five-year survival rate for all patients diagnosed with NPC is approximately 60%, however, those who are diagnosed with advanced disease have a five-year survival rate of approximately 49%.
Due to the location of the primary tumor, surgery is rarely an option, and patients with localized disease are treated primarily with radiation and chemotherapy. Patients treated with chemotherapy alone experience poor prognosis: only 20% experience one-year PFS; up to 50% developed distant metastasis during their disease course; and low median OS of 29 months.
LOQTORZI™ is the first FDA-approved therapy for NPC and will represent a new standard of care for treating the disease when used in combination with cisplatin and gemcitabine in the first line setting or as monotherapy in the second line or greater setting.
About LOQTORZI™ (toripalimab-tpzi)
LOQTORZI is a next generation anti-PD-1 monoclonal antibody that blocks PD-L1 binding to the PD-1 receptor at a unique site with high affinity and activates antitumor immunity demonstrating improvement in the overall survival of cancer patients in several tumor types.
INDICATIONS AND IMPORTANT SAFETY INFORMATION
INDICATIONS
LOQTORZI (toripalimab-tpzi) is indicated:
- In combination with cisplatin and gemcitabine, for the first-line treatment of adults with metastatic or with recurrent, locally advanced nasopharyngeal carcinoma (NPC).
- As a single agent, for the treatment of adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy.
Please see Prescribing Information for LOQTORZI and Medication Guide
About Coherus BioSciences
Coherus is a commercial-stage biopharmaceutical company focused on the research, development and commercialization of innovative immunotherapies to treat cancer. Coherus is developing an innovative immuno-oncology pipeline that will be synergistic with its proven commercial capabilities in oncology.
Coherus’ immuno-oncology pipeline includes multiple antibody immunotherapy candidates focused on enhancing the innate and adaptive immune responses to enable a robust immunologic response and enhance outcomes for patients with cancer. Casdozokitug is a novel anti-IL-27 antibody currently being evaluated in two on-going clinical studies: a Phase 1/2 study in advanced solid tumors and a Phase 2 study in hepatocellular carcinoma. CHS-114 is a highly selective, competitively positioned, ADCC-enhanced anti-CCR8 antibody currently in a Phase 1/2 study as a monotherapy in patients with advanced solid tumors.
Coherus’ earlier-stage immuno-oncology pipeline targets immune-suppressive mechanisms, including CHS-006, a TIGIT-targeted antibody, being evaluated in a Phase 1/2 clinical trial in combination with LOQTORZI in patients with advanced solid tumors, and CHS-1000, a preclinical program targeting the novel pathway ILT4.
Coherus markets UDENYCA® (pegfilgrastim-cbqv), a biosimilar of Neulasta®, CIMERLI® (ranibizumab-eqrn), a biosimilar of Lucentis®, YUSIMRY™ (adalimumab-aqvh), a biosimilar of Humira® and LOQTORZI (toripalimab-tpzi), a novel next generation PD-1 inhibitor.
SOURCE: Coherus BioSciences
Post Views: 413
– Launch of LOQTORZI offers first and only FDA-approved treatment for NPC in all lines of therapy –
– Indicated in combination with chemotherapy for 1st line treatment and as monotherapy for patients with disease progression on or after platinum containing chemotherapy, irrespective of PD-L1 status –
– LOQTORZI is now available for purchase through select specialty distributors –
REDWOOD CITY, CA, USA I January 02, 2024 I Coherus BioSciences, Inc. (“Coherus,” NASDAQ: CHRS) today announced that LOQTORZI™ (toripalimab-tpzi) is now available through select specialty distributors in the United States. LOQTORZI is indicated in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC), and as monotherapy for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy. LOQTORZI is a next-generation, programmed death receptor-1 (PD-1) monoclonal antibody that blocks PD-1 ligands PD-L1 and PD-L2 with high potency at a unique site on the PD-1 receptor, enabling the immune system to activate and kill the tumor.
“For people with rare cancers such as NPC, the prognosis is poor and treatment options have been limited,” said John Hopper, Founder of the Patient Activation Group, Co-Chair of the NORD Rare Cancer Coalition and board director of rare cancer foundation-SARC (Sarcoma Alliance for Research through Collaboration). “The availability of LOQTORZI as a new treatment option for advanced NPC represents a meaningful step forward for NPC patients and gives further hope to rare cancer advocates that there will be more options for rare cancer patients in the future.”
NPC affects approximately 2000 patients in the U.S. annually. Until now the standard of care was chemotherapy. In December, the NCCN committee classified LOQTORZI as a preferred category 1 treatment option in combination with gemcitabine and cisplatin. The decision was based on results of the JUPITER-02 Phase 3 study and the POLARIS-02 Phase 2 study. In the JUPITER-02 Phase 3 study, LOQTORZI combined with chemotherapy significantly improved progression-free survival (PFS), reducing the risk of disease progression or death by 48% compared to chemotherapy alone. LOQTORZI also demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS), with treatment resulting in a 37% reduction in the risk of death versus chemotherapy alone. In the POLARIS-02 clinical study, LOQTORZI demonstrated durable anti-tumor activity in patients with recurrent or metastatic NPC who failed previous chemotherapy, with an objective response rate (ORR) of 20.5%, a disease control rate (DCR) of 40.0%, and a median OS of 17.4 months with an acceptable safety profile.
“We are proud to bring LOQTORZI to a patient population that has had no FDA-approved options available, and our mission is to establish LOQTORZI plus chemotherapy as the new standard of care for relapsed/metastatic NPC. LOQTORZI has demonstrated impressive clinical benefits, including PFS and OS, offering R/M NPC patients new hope for extended survival,” said Paul Reider, Chief Commercial Officer of Coherus. “As the first and only FDA-approved treatment for this type of cancer, we’ll work tirelessly to support physician education and patient access, while activating the NPC patient community through our partnership with patient advocacy groups and our own NPCfacts.com community.”
“The launch of LOQTORZI is a foundational milestone, signaling Coherus’ emergence as a commercial-stage immuno-oncology company,” said Denny Lanfear, Chairman and Chief Executive Officer of Coherus. “We believe LOQTORZI will play a key role in next-generation novel immuno-oncology treatment combinations aimed at extending patient survival across multiple tumor types through our own internal pipeline as well as our external collaborations.”
LOQTORZI is commercially available for purchase through select specialty distributors including Cencora (formerly ABC), Cardinal and McKesson. Each carton contains one 240 mg/6 mL (40 mg/mL) single-dose vial. Contact Coherus BioSciences Customer Services at 1-844-562-6004 for more information. LOQTORZI Solutions™ for HCPs is now online and offers healthcare professionals comprehensive practice and patient support that includes extensive patient assistance and office resources to ensure successful access and reimbursement. Billing will occur under the medical benefit using an Unclassified HCPCS code J3490 or J3590 with a unique NDC number of 70114-0340-01. Coherus expects a product-specific, permanent J-code to be assigned to LOQTORZI in mid-2024.
About LOQTORZI Solutions™
Coherus is committed to supporting patients with programs for zero out-of-pocket costs or patient assistance for eligible patients so that they may benefit from a proven PD-1 immunotherapy, with less financial burden. Through LOQTORZI Solutions, our robust patient support services include reimbursement support, patient support, and access support. More specific product information can be found on LOQTORZI.com.
Commitment to the NPC community
Given the limited resources available to patients and caregivers contending with NPC, Coherus has launched a new educational community resource, NPCFacts.com, which includes detailed information about the types of NPC as well as its causes, diagnosis, and treatment options. Currently there are over 2000 patients and caregivers enrolled in this program and product education is underway.
In addition to education about nasopharyngeal carcinoma, the website includes links to patient advocacy organizations providing additional resources, including the Head and Neck Cancer Alliance, Support for People with Oral Head and Neck Cancer, and Thyroid Head and Neck Cancer Foundation. The website includes a companion website for healthcare professionals treating patients with NPC, including educational resources and opportunities for peer-to-peer education.
About NPC
NPC is a type of aggressive cancer that starts in the nasopharynx, the upper part of the throat behind the nose and near the base of the skull. NPC is rare in the United States, with an annual incidence of fewer than one per 100,000. The five-year survival rate for all patients diagnosed with NPC is approximately 60%, however, those who are diagnosed with advanced disease have a five-year survival rate of approximately 49%.
Due to the location of the primary tumor, surgery is rarely an option, and patients with localized disease are treated primarily with radiation and chemotherapy. Patients treated with chemotherapy alone experience poor prognosis: only 20% experience one-year PFS; up to 50% developed distant metastasis during their disease course; and low median OS of 29 months.
LOQTORZI™ is the first FDA-approved therapy for NPC and will represent a new standard of care for treating the disease when used in combination with cisplatin and gemcitabine in the first line setting or as monotherapy in the second line or greater setting.
About LOQTORZI™ (toripalimab-tpzi)
LOQTORZI is a next generation anti-PD-1 monoclonal antibody that blocks PD-L1 binding to the PD-1 receptor at a unique site with high affinity and activates antitumor immunity demonstrating improvement in the overall survival of cancer patients in several tumor types.
INDICATIONS AND IMPORTANT SAFETY INFORMATION
INDICATIONS
LOQTORZI (toripalimab-tpzi) is indicated:
- In combination with cisplatin and gemcitabine, for the first-line treatment of adults with metastatic or with recurrent, locally advanced nasopharyngeal carcinoma (NPC).
- As a single agent, for the treatment of adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy.
Please see Prescribing Information for LOQTORZI and Medication Guide
About Coherus BioSciences
Coherus is a commercial-stage biopharmaceutical company focused on the research, development and commercialization of innovative immunotherapies to treat cancer. Coherus is developing an innovative immuno-oncology pipeline that will be synergistic with its proven commercial capabilities in oncology.
Coherus’ immuno-oncology pipeline includes multiple antibody immunotherapy candidates focused on enhancing the innate and adaptive immune responses to enable a robust immunologic response and enhance outcomes for patients with cancer. Casdozokitug is a novel anti-IL-27 antibody currently being evaluated in two on-going clinical studies: a Phase 1/2 study in advanced solid tumors and a Phase 2 study in hepatocellular carcinoma. CHS-114 is a highly selective, competitively positioned, ADCC-enhanced anti-CCR8 antibody currently in a Phase 1/2 study as a monotherapy in patients with advanced solid tumors.
Coherus’ earlier-stage immuno-oncology pipeline targets immune-suppressive mechanisms, including CHS-006, a TIGIT-targeted antibody, being evaluated in a Phase 1/2 clinical trial in combination with LOQTORZI in patients with advanced solid tumors, and CHS-1000, a preclinical program targeting the novel pathway ILT4.
Coherus markets UDENYCA® (pegfilgrastim-cbqv), a biosimilar of Neulasta®, CIMERLI® (ranibizumab-eqrn), a biosimilar of Lucentis®, YUSIMRY™ (adalimumab-aqvh), a biosimilar of Humira® and LOQTORZI (toripalimab-tpzi), a novel next generation PD-1 inhibitor.
SOURCE: Coherus BioSciences
Post Views: 413
