Results

Bristol-Myers’ tarnished checkpoint star Opdivo beats out Yervoy in surprise PhIII

Bristol-Myers got a much-needed boost with the earlier-than-expected news that Opdivo beat out Yervoy in a Phase III study focused on a particular niche for adjuvant melanoma therapy. And an analyst who’s been following the data says it could be worth a billion dollars in added annual sales.

The big biotech says an interim analysis of Checkmate-238 provided researchers with proof that the PD-1 drug outperformed Yervoy, Bristol-Myers’ CTLA-4 drug, among advanced Stage IIIb or IV patients, cutting the recurrence rate for those who have undergone surgery. There are no bottom line numbers in the statement, but Bristol-Myers says they’ll be able to release data at an upcoming conference to show that Opdivo provided a significantly lower risk of disease recurrence.

Seamus Fernandez notes that the results are likely to cannibalize Bristol’s Yervoy revenue, but will likely deliver a $1 billion boost to Opdivo as physicians steer away from the higher doses of highly toxic Yervoy. He noted:

This comes as a surprise, as top-line data were not expected until the final readout in 2H:18. While there were no details in the press release regarding the magnitude of benefit for Opdivo, we would expect it to become the standard of care in high-risk patients following surgical resection given its superior safety and tolerability profile relative to Yervoy. We estimate the adjuvant melanoma market will expand PD1 sales by approximately $3B globally. Although this likely will cannibalize sales of Yervoy in the setting (we estimate current adjuvant Yervoy sales at $300-400M), the expansion of the market should add approximately $1B to BMY’s net immuno-oncology (IO) sales despite assumed competition from MRK’s (MP) Keytruda (pembrolizumab; anti-PD-1).

Vicki Goodman

Opdivo’s rocky road at Bristol has led to endless speculation that the company could find itself on the auction block before it gets a chance to reorganize in the clinic and come back in its head-to-head showdown with Merck’s Keytruda. But it is also racking up billions in annual sales of Opdivo, with a slate of new trials underway.

“These topline results support the potential promise of Opdivo as a treatment option for patients with high-risk surgically resected melanoma. There remains an unmet need for additional options as the majority of stage III and resected stage IV high-risk melanoma patients experience disease recurrence after surgery,” said Vicki Goodman, development lead, melanoma and genitourinary cancers, Bristol-Myers Squibb. “We are committed to researching therapies that may better meet the needs of this patient population and look forward to sharing these data with health authorities soon.”

Jeffrey Weber

Physicians in the field, including the high profile Jeffrey Weber at NYU Langone, have been waiting to see how this one will shake out. And they’re getting the readout a year ahead of schedule. In a panel chat with experts in the field in the spring of 2016, he noted:

On the basis of my own experience with both drugs in pilot adjuvant trials, I have a suspicion that nivolumab is going to look better than ipilimumab. And the next frontier is what we’ve already piloted when I was at Moffitt and we’ll continue at NYU, which is combination adjuvant therapy. But because of the toxicity, we flipped the doses giving one of ipilimumab and three of nivolumab, which is very well-tolerated with a pretty good track record, admittedly, in a small study. So, I think that we’ve gone from interferon, we’ll go to ipilimumab, we’ll go to nivolumab, and eventually end up at ipilimumab plus nivolumab, over the next five years, which brings us to where we’re going in metastatic treatment. I think we’re going to see triple combinations. On the one hand, it’s scientifically fascinating, extremely complex with paradoxically a bar that’s now so high, it’s going to be very difficult to get combinations approved. You’re going to need to see major incremental advantages, which I think you probably will see with some of the drugs my colleagues have mentioned. But they’re also going to be very expensive, so pharmacoeconomics is also going to play a huge role in what we do. Right now, I would estimate that the cost of ipilimumab plus nivolumab therapy for a year is about $250,000. So, I would ask where does this all end?


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RAPS Regulatory Convergence 2017