Policy & Regulation
Bristol-Myers Squibb Says Phase 3 CheckMate -331 Study Does Not Meet Primary Endpoint of Overall Survival with Opdivo Versus Chemotherapy in Patients with Previously Treated Relapsed Small Cell Lung Cancer
12 October 2018 - - US-based biopharmaceutical company Bristol-Myers Squibb Company (NYSE: BMY) has received topline results from the Phase 3 CheckMate -331 study evaluating Opdivo (nivolumab) versus the current standard of care, topotecan or amrubicin (where approved), in patients with small cell lung cancer who relapsed following platinum-based chemotherapy, the company said.

The study did not meet its primary endpoint of overall survival with Opdivo versus chemotherapy. The safety profile of Opdivo in this trial was consistent with that observed in previously reported monotherapy studies involving patients with SCLC.

Bristol-Myers Squibb has a development programme in thoracic malignancies, including SCLC, non-small cell lung cancer and malignant pleural mesothelioma.

As part of this program, the company is investigating the role of Opdivo plus Yervoy and Opdivo monotherapy versus placebo in the frontline setting as a maintenance therapy for patients with SCLC who do not progress on first-line chemotherapy.

CheckMate -331 is an open-label, randomized Phase 3 study evaluating Opdivo monotherapy versus chemotherapy in patients with relapsed small cell lung cancer following platinum-based chemotherapy.

Patients were randomised to two treatment arms: an experimental arm assessing Opdivo; and an active comparator arm evaluating topotecan (or amrubicin, upon investigator's choice, where locally approved for second-line SCLC treatment).

The primary objective was overall survival. Secondary endpoints included progression-free survival and objective response rate.

Lung cancer is the leading cause of cancer deaths globally, resulting in nearly 1.8 m deaths each year, according to the World Health Organization.

Small cell lung cancer is one of two main types of lung cancer and accounts for about 10% to 15% of all lung cancers.

SCLC is an aggressive disease and symptoms often are not detected until the cancer is at an advanced stage.

Chemotherapy has been the standard of care in the front-line setting, with or without radiation therapy. Despite responding to initial treatment, the majority of patients experience relapse within one year (the return of disease after a period of improvement). From the time of diagnosis, the median range of survival for extensive-stage SCLC (ES-SCLC) patients is between eight and 13 months.

Less than 5% of patients with ES-SCLC survive two years and the five-year survival rate is 1% to 2%.
Opdivo is a programmed death-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 global development programme 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 65 countries, including the United States, the European Union, Japan and China.

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.

In 2011, through a collaboration agreement with Ono Pharmaceutical Co., Bristol-Myers Squibb expanded its territorial rights to develop and commercialise 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 commercialise multiple immunotherapies as single agents and combination regimens for patients with cancer in Japan, South Korea and Taiwan.