Two Pivotal Opdivo (nivolumab) Trials Show Three-Year Survival Benefit in Patients with Previously Treated Advanced Non-Small Cell Lung Cancer

Data continued to show benefit with Opdivo in overall population, with nearly triple (CheckMate -017) and double (CheckMate -057) the patients alive at three years compared to docetaxel

Results represent the longest Phase 3 follow-up data reported for a PD-1 inhibitor in second-line non-small cell lung cancer

Safety profile of Opdivo with minimum follow-up of three years was consistent with previous reports of both data sets

PRINCETON, NJ, USA I September 8, 2017 I Bristol-Myers Squibb Company (NYSE:BMY) today announced three-year overall survival (OS) data from CheckMate -017 and CheckMate -057, two pivotal Phase 3 randomized studies evaluating Opdivo versus docetaxel in patients with previously treated metastatic non-small cell lung cancer (NSCLC). In CheckMate -017, a trial in previously treated squamous NSCLC, 16% of patients treated with Opdivo were alive at three years (21/135) versus 6% of those treated with docetaxel (8/137) (HR 0.62; 95% CI: 0.48 to 0.80). In CheckMate -057, a trial in previously treated non-squamous NSCLC, 18% of patients treated with Opdivo were alive at three years (49/292) versus 9% of those treated with docetaxel (26/290) (HR 0.73; 95% CI: 0.62 to 0.88). Similar to prior reports, an OS benefit was observed across histologies, and three-year survivors included patients whose tumors expressed PD-L1 and those that did not. With three years’ minimum follow-up, no new safety signals were identified for Opdivo, and the safety profile across both trials was consistent with prior reports.

Enriqueta Felip, M.D., head of the Thoracic Tumors Group, Vall d’Hebron Institute of Oncology, Barcelona, Spain, commented, “Opdivo is already a standard of care in previously treated non-small cell lung cancer across histologies, demonstrating durable, long-term survival in two pivotal Phase 3 studies. Data from CheckMate -017 and CheckMate -057 continue to reinforce the compelling and sustained survival benefit demonstrated with Opdivo for these patients even after three years. These results are important for the clinical community and represent the longest follow-up data reported for a PD-1 inhibitor versus chemotherapy in second-line NSCLC.”

These data will be presented on Sunday, September 10 at the European Society for Medical Oncology 2017 Congress in Madrid, Spain, during the NSCLC, Metastatic Poster Discussion Session from 4:30-6 PM CEST in the Barcelona Auditorium (Abstract #1301PD).

Nick Botwood, M.D., development lead, thoracic cancers, Bristol-Myers Squibb, commented, “Our utmost priority at BMS is to bring forth transformational medicines to deliver what matters most to patients fighting cancer: long-term survival. The long-term survival benefit seen with Opdivo in the pivotal CheckMate -017 and -057 studies demonstrates our commitment to this vision. These data also increase our understanding of the value Opdivo may bring to patients with previously treated metastatic NSCLC, as we continue to explore Opdivo alone and in combination with other agents across a range of thoracic cancers.”

About CheckMate -017 & CheckMate -057

CheckMate -017 and CheckMate -057 are two pivotal Phase 3, open-label, randomized clinical trials that evaluated Opdivo 3 mg/kg every two weeks versus standard of care, docetaxel 75 mg/m2 every three weeks, in patients with advanced NSCLC who had progressed during or after one prior platinum doublet-based chemotherapy regimen. CheckMate -017 included 272 patients with squamous NSCLC, and CheckMate -057 included 582 patients with non-squamous NSCLC. Both trials enrolled patients across PD-L1 expression levels. The primary endpoint for both trials was overall survival (OS), and secondary endpoints included objective response rate (ORR), progression-free survival (PFS) and efficacy by tumor PD-L1 expression.

In both studies, the OS benefit for Opdivo was observed across PD-L1 expression levels, including patients with PD-L1 expression <1%. Among Opdivo-treated patients with squamous NSCLC in CheckMate -017, 13% (7/54) with PD-L1 expression <1% and 14% (9/63) with PD-L1 expression ≥1% were alive at three years. In non-squamous NSCLC patients treated with Opdivo in CheckMate -057, 11% (11/108) with PD-L1 expression <1% and 26% (29/123) with PD-L1 expression ≥1% were alive at three years.

The safety profile of Opdivo remained consistent with previous reports of data from both pivotal trials. In the pooled safety analysis, at three years, 10.5% of Opdivo-treated patients experienced Grade 3/4 treatment-related adverse events (AEs). The most common treatment-related AEs of any grade in patients treated with Opdivo included fatigue (17%), nausea (11%), decreased appetite (11%), asthenia (10.5%), pruritus (6.9%) and vomiting (5%).

About Lung Cancer

Lung cancer is the leading cause of cancer deaths globally, resulting in nearly 1.7 million deaths each year, according to the World Health Organization. NSCLC is one of the most common types of the disease and accounts for approximately 85% of diagnoses. About 25% to 30% of all lung cancers are squamous cell carcinomas, and non-squamous NSCLC accounts for approximately 50% to 65% of all lung cancer diagnoses. Survival rates vary depending on the stage and type of the cancer when diagnosed. Globally, the five-year survival rate for patients with Stage I NSCLC is between 47% and 50%, and for Stage IV NSCLC, the five-year survival rate drops to 2%.

Bristol-Myers Squibb & Immuno-Oncology: Advancing Oncology Research

At Bristol-Myers Squibb, patients are at the center of everything we do. Our vision for the future of cancer care is focused on researching and developing transformational Immuno-Oncology (I-O) medicines for hard-to-treat cancers that could potentially improve outcomes for these patients.

We are leading the scientific understanding of I-O through our extensive portfolio of investigational compounds and approved agents. Our differentiated clinical development program is studying broad patient populations across more than 50 types of cancers with 14 clinical-stage molecules designed to target different immune system pathways. Our deep expertise and innovative clinical trial designs position us to advance I-O/I-O, I-O/chemotherapy, I-O/targeted therapies and I-O/radiation therapies across multiple tumors and potentially deliver the next wave of therapies with a sense of urgency. We also continue to pioneer research that will help facilitate a deeper understanding of the role of immune biomarkers and how patients' tumor biology can be used as a guide for treatment decisions throughout their journey.

We understand making the promise of I-O a reality for the many patients who may benefit from these therapies requires not only innovation on our part but also close collaboration with leading experts in the field. Our partnerships with academia, government, advocacy and biotech companies support our collective goal of providing new treatment options to advance the standards of clinical practice.

About Opdivo

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

Opdivo’s leading global development program is based on Bristol-Myers Squibb’s scientific expertise in the field of Immuno-Oncology and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has enrolled more than 25,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression.

In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 60 countries, including the United States, the European Union and Japan. In October 2015, the company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union.

U.S. FDA-APPROVED INDICATIONS FOR OPDIVO ®

OPDIVO® (nivolumab) as a single agent is indicated for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

OPDIVO® (nivolumab) as a single agent is indicated for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic melanoma. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

OPDIVO® (nivolumab) is indicated for the treatment of 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) is indicated for the treatment of 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 classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous HSCT. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab) is indicated for the treatment of 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 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. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab) is indicated for the treatment of adults and pediatric (12 years and older) patients with microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Checkmate Trials and Patient Populations

Checkmate 067 - advanced melanoma alone or in combination with YERVOY; Checkmate 037 and 066 - advanced melanoma; Checkmate 017 - squamous non-small cell lung cancer (NSCLC); Checkmate 057 - non-squamous NSCLC; Checkmate 025 - renal cell carcinoma; Checkmate 205/039 - classical Hodgkin lymphoma; Checkmate 141 - squamous cell carcinoma of the head and neck; Checkmate 275 - urothelial carcinoma.

About the Bristol-Myers Squibb and Ono Pharmaceutical Co., Ltd. Collaboration

In 2011, through a collaboration agreement with Ono Pharmaceutical Co., Ltd. (Ono), 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, Bristol-Myers Squibb and Ono 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, Twitter, YouTube and Facebook.

SOURCE: Bristol-Myers Squibb

La Merie Biologics

FREE Weekly News Bulletin

2016 Sales ofAntibodies & Proteins

New Product Alert

For La Merie Publishing

Top