Bristol-Myers Squibb ($BMY) has rolled out more significant findings for its standout cancer fighter Opdivo, one of the immuno-oncology drugs on which it has staked its future. It released two sets of data, one showing that more than a third of patients taking it to treat advanced melanoma survived for 5 years.
Specifically, the data showed a 5-year survival rate for 34% of patients with advanced melanoma whose previous treatments had been unable to stop the aggressive cancer. That is well above the 15% to 20% expected for those with stage IV cancer.
The data was from patients that had started in an early trial of Opdivo, which was approved by the FDA to treat melanoma in 2014. BMS said that there was an evident plateau in survival at approximately four years, with side effects being similar to earlier reports.
The findings were released Sunday at the American Association for Cancer Research in New Orleans, along with data showing that Opdivo in combination with Yervoy, another so-called checkpoint inhibitor from BMS, displayed a two-year overall survival rate of 69% in patients with BRAF wild-type advanced melanoma. It said 22% of patients achieved a complete response.
“The data from CheckMate -069 and study -003 showed durable responses for some patients with advanced melanoma using new Immuno-Oncology approaches,” Dr. F. Stephen Hodi, director of the Melanoma Center at Dana-Farber Cancer Institute and associate professor of medicine at Harvard Medical School, said in a statement. “These data contribute to our growing understanding of this aggressive cancer and are promising news for advanced melanoma patients.”
Oncologists told the Wall Street Journal that the particular significance of the results of using the checkpoint inhibitors is they indicate that patients who survive a certain length of time--three years in the case of Yervoy and about four years for Opdivo--will probably not recur. Their immune systems appear to eradicate or control their tumors.
The new data should help the drug combo treatment grab more market share. Last fall , the FDA approved Yervoy and Opdivo in tandem to treat patients with advanced melanoma and a particular genetic variation. The two-drug cocktail comes with a price tag of $141,000 for a four-dose course of treatment, or $256,000 for a year's worth of therapy.
Bristol-Myers is hoping that the enhanced benefits of the cocktail will give Opdivo an advantage in melanoma over Merck & Co.'s ($MRK) competitor Keytruda. The rival drugs were the first immuno-oncology treatments approved and they've been racing to gain market share by adding new approvals in various patient groups and cancer types.
Merck secured the first FDA approval for a PD-1 inhibitor in 2014 when Keytruda won agency clearance as a second-line melanoma treatment, but Bristol-Myers quickly caught up with approvals in skin and lung cancers. It now has 5 approvals, including for kidney cancer.
With each new approval, Opdivo racks up more impressive sales numbers. It helped BMS top Q4 2015 expectations with a big leap in sales to $475 million, and is poised to do it again for the Q1 2016. Evercore ISI analyst Mark Schoenebaum last week told investors that February sales figures from IMS Health indicate that Opdivo will again top analyst expectations.
- here’s the release .
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