BMS’ Opdivo improves lung cancer survival

pharmafile | May 29, 2015 | News story | Research and Development, Sales and Marketing ASCO, BMS, Bristol-Myers Squibb, NSCLC, lung cancer, nivolumab, non-small cell lung cancer, opdivo 

A Phase III trial of Bristol-Myers Squibb’s immunotherapy Opdivo has found it increases overall survival in people with a common form of lung cancer.

The CHECKMATE-057 trial, presented at the American Society of Clinical Oncology conference in Chicago, found that Opdivo (nivolumab) – a drug in a new class of cancer immunotherapy treatments – improved survival in non squamous non-small cell lung cancer (non-SQ NSCLC) more than chemotherapy. 

The Phase III study, of 582 previously-treated patients, compared treatment with Opdivo with chemotherapy with docetaxel.

People treated with Opdivo were 27% more likely to survive during the study than people who were treated with chemotherapy. The study found that the average overall survival was over 12 months in people treated with Opdivo, compared to over nine months in people who had chemotherapy.

People who had tumours that expressed PD-L1 proteins showed more benefit – which reached a 60% survival benefit in people with the highest levels of PD-L1 expression.

High-grade drug-related adverse events occurred in 10.5% of people in the Opdivo group and 53.7% of people in the chemo group.

Opdivo is already EU-approved for melanoma, but industry analysts have been keenly watching the drug’s performance as a NSCLC treatment – for which the market is far bigger. This form of lung cancer affects 85% of people with the disease. It is already approved in this patient group by the FDA. 

Earlier in May the EMA gave Opdivo a positive opinion as a treatment for NSCLC, and if it is approved by the European Commission it will become the first EU-approved immunotherapy treatment for this patient group. 

The trial had been stopped early in January after independent assessors decided that the study met its endpoint.

“This marks the end of the chemotherapy era in second-line treatment of lung cancer,” says Fouad Namouni, vice president and development lead in immuno-oncology at Bristol-Myers Squibb.

Michael Giordano, BMS senior vice president and head of development, oncology, adds: “This represents a significant scientific advance in non-small cell lung cancer.”

Dr Luis Paz-Ares, one of the study researchers from the Hospital Universitario Doce de Octubre in Madrid, Spain, says: “Our goal with clinical cancer research is to always look for new options that may improve upon, or in some cases replace, current standard of care. The results represent progress toward establishing a new standard of care that may replace docetaxel in PD-L1 expressers.”

Lilian Anekwe

The ASCO abstract is available here.

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