BMS’ Opdivo wins US lung cancer race

The FDA has approved Bristol-Myers Squibb’s Opdivo (nivolumab) for the treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC).

The recommendation means BMS is the first to have a new type of cancer immunotherapy, called anti-PD-1 (programmed death receptor-1), to be approved for people who have lung cancer who have already been treated with progression on or after platinum-based chemotherapy.

Its speedy approval means that made it through the assessment process more than three months ahead of its deadline, making it one of the fastest priority review drug approvals in FDA history. It is the second Opdivo recommendation in the US in the last three months – the FDA approved it as a treatment for advanced melanoma that cannot be surgically removed in December.

The lung cancer decision is based on Phase III trial results that showed Opdivo demonstrated better overall survival compared to the current standard treatment docetaxel, with a 41% reduction in the risk of death, and median overall survival of just over nine months longer after six month compared to people who were treated with docetaxel.

The trial was stopped early in January after Opdivo an assessment panel concluded the study had met its stated endpoint.

The approval significantly expands the potential market for Opdivo, and offers BMS the advantage over its competitor, Merck’s Keytruda (pembrolizumab), in being first to the US market. Lung cancer could add billions of dollars in annual sales for Opdivo.

It is one of the leading causes of cancer deaths in the US, where NSCLC accounts for around 85% of cases, and squamous cell NSCLC accounts for around 25-30% of all lung cancers.

Richard Pazdur, the FDA's head of haematology and oncology product evaluation, says: "This approval will provide patients and health care providers knowledge of the survival advantage associated with Opdivo and will help guide patient care and future lung cancer trials."

Dr Suresh Ramalingam, professor and director of medical oncology at Emory University, adds: “The FDA approval of Opdivo introduces an entirely new treatment modality that has demonstrated unprecedented results for the treatment of previously treated metastatic squamous NSCLC, with the potential to replace chemotherapy for these patients. This milestone brings to fruition the long-held hope that immuno-oncology medicines can be significantly effective in this difficult-to-treat population.”

BMS has reinforced its credentials in immuno-oncology by signing a $975 million agreement – including a $60 million upfront payment – with Bavarian Nordic for exclusive rights to Prostvac (vaccinia-fowlpox/TRICOM), an investigational immunotherapy for metastatic prostate cancer that is in ongoing Phase III trials. And in February the company announced a deal to acquire Flexus Biosciences, which develops novel oncology drugs, for $1.25 billion.

Lamberto Andreotti, who is chief executive officer at BMS, says: “We are pleased to offer Opdivo as the first immuno-oncology therapy for patients who have previously treated metastatic squamous NSCLC. 

"Because lung cancer is one of the most commonly diagnosed cancers in the US, with high mortality, there is a significant need for treatments that extend survival. We’re thankful to the many patients and healthcare providers that partnered with us to develop a new treatment that has the potential to address that unmet need.”

Lilian Anekwe