BMS lung cancer drug scores in Phase II
pharmafile | October 31, 2014 | News story | Sales and Marketing | BMS, Bristol-Myers Squibb, Cancer, FDA, NSCLC, bristol myers-squibb, odivo
Bristol-Myers Squibb is still in the hunt to gain significant market share in the PD-1 therapeutic vaccine race after releasing positive mid-stage data for its new drug Opdivo.
The treatment, which is already approved in Japan for melanoma, saw 41% of lung cancer patients still alive after one year’s treatment with the medicine.
Opdivo (nivolumab) was not tested against a rival drug or placebo in the 117 patient trial however, but rather used the objective response rate (ORR) as its primary endpoint. The data showed the ORR for this trial was 15% – much higher than was expected.
The drug was given to patients with advanced squamous cell non-small cell lung cancer (NSCLC) who have progressed after at least two prior systemic treatments, with 65% receiving three or more prior therapies. Squamous cell NSCLC tends to present in the centre of the lung, making surgery more difficult and lowering a patient’s outlook.
“The data today look very, very good,” says ISI Group analyst Mark Schoenebaum, adding that it bodes well for an ongoing Phase III trial in NSCLC patients following just one prior therapy. He had estimated a one-year survival rate of about 20% as the number to beat.
“The Phase II findings from CheckMate -063 are encouraging as there are no effective treatment options for patients with refractory squamous cell lung cancer after their disease has progressed through two prior therapies,” adds Suresh Ramalingam, professor and director of medical oncology at Winship Cancer Institute of Emory University.
“The results are also consistent with Phase I data previously reported from Study -003.” Historically, the expected one-year survival rate for third-line squamous cell NSCLC patients is approximately 5.5% – 18 per cent.”
The firm says it submitted the drug on a rolling submission basis with the FDA in April and expects this to be completed by the end of the year.
Rivals and new licences
But Opdivo is still awaiting approval in the US with the FDA expected to make a decision on its drug for a new melanoma licence – although this is not expected until early next year.
Because of this, it lost out in the race to the new PD-1 melanoma market with fierce rival Merck, which saw its PD-1 drug Keytruda (pembrolizumab) gain US approval for melanoma last month.
But despite being second to market (should it see an FDA green light next year) if BMS sees approvals for both melanoma and NSCLC, Sanford Bernstein analyst Tim Anderson says Opdivo sales could reach a healthy $4.6 billion in 2020.
Merck submitted Keytruda to the EMA in July, with a decision on the drug expected early next year, meaning it could also be the first PD-1 to be approved in Europe. But BMS will likely not be far behind given that it has also submitted its drug to the EMA and was granted an accelerated approval path in late September.
Merck is also studying the drug in more than 30 different types of tumours including studies in lung, bladder and gastric cancers.
Roche and AstraZeneca also have PD-1 inhibitors in the pipeline, but neither are as advanced as Opdivo or Keytruda. Analysts expect this new market to be worth around $30 billion per year in the next decade, should all four drugs gain approval.
Lung is the leading cause of cancer deaths globally, with about 1.5 million each year, according to the World Health Organization and NSCLC accounts for around 85% of all lung cancer cases.
Ben Adams
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