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The Pulse of the Pharmaceutical Industry

Bristol-Myers’ Lung Cancer Opdivo Trial Stopped Early for Superior Overall Survival

Written by: | | Dated: Friday, December 1st, 2017


By Alex Keown


Bristol-Myers Squibb has its eyes set on carving out a strong position in the lucrative Chinese lung cancer market. On Thursday night, the company announced its Phase III trial pitting Opdivo against chemotherapy drug docetaxel in treating certain lung cancer patients was stopped early after meeting key endpoints.

BMS said the Independent Data Monitoring Committee ruled Opdivo demonstrated superior overall survival in patients with previously treated advanced or metastatic non-small cell lung cancer (NSCLC). Based on the committee’s report, BMS said it has submitted a Biologics License Application (BLA) for Opdivo to the China Food and Drug Administration for the proposed indication. The Chinese regulatory agency accepted the BLA, the company added. Lung cancer is the leading cause of cancer-related deaths in China.

While the Chinese regulatory agency has full trial data, BMS said it will work with investigators on the future presentation and publication of the results.

Nick Botwood, head of thoracic cancers at BMS, said the Phase CheckMate-078 trial marked the third time Opdivo, a PD-1 inhibitor, demonstrated a survival advantage in previously treated metastatic non-small cell lung cancer.

“In China, where lung cancer is the leading cause of cancer death, these results are especially important, as they represent the first Phase 3 trial to show an overall survival benefit with a PD-1 inhibitor in the Chinese patient population. Through our Opdivo clinical development program, we aim to bring the potential for long-term survival to patients where significant unmet medical needs remain,” Botwood said in a statement.

Lead trial investigator Yi-Long Wu, chairman of the Chinese Thoracic Oncology Group, said that based on the CheckMate-078 topline results Opdivo has the potential to become the first immuno-oncology treatment approved for previously treated lung cancer patients in China.

“I hope that Chinese patients with NSCLC can benefit from this groundbreaking I-O treatment as early as possible,” Wu said.

Shares of BMS rose slightly in after-market trading on Thursday to hit $63.60.

Lung cancer is the most commonly diagnosed cancer in China. In 2015, there were 733,000 cases diagnosed and that is predicted to pass 800,000 by the year 2020. Of those newly diagnosed cases, BMS said about 68 percent of lung cancer patients in China are already at an advanced stage. NSCLC is one of the most common types of the disease and accounts for approximately 85 percent of diagnoses, BMS said. Additionally BMS said about 25 percent to 30 percent of all lung cancers in China are squamous cell carcinomas. Non-squamous NSCLC accounts for approximately 50 percent to 65 percent of all lung cancer diagnoses, according to statistics shared by BMS. Survival rates vary depending on the stage and type of the cancer when diagnosed.

Part of the reason for the soaring number of lung cancers in China is poor air quality.  In September, USA Today reported that high rates of air pollution in China, particularly in the northern parts of the country, are reducing the life span of its people by about three years.


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