The outlook brightened today for Bristol-Myers Squibb’s Opdivo as combo med as the drugmaker released more results from a test of its Opdivo-plus-Yervoy combination as a first-line treatment in kidney cancer. The overall survival results were promising enough that BMS stopped the trial early.
Today's report led one analyst to predict “a very high likelihood of approval” as a first-line treatment in renal cell carcinoma. It is the most common form of kidney cancer in adults and an area in which some forecasters think that Opdivo could eventually derive $2 billion in sales.
The data was from a trial of Opdivo along with Yervoy in patients with previously untreated advanced or metastatic renal cell carcinoma. BMS said the combo met the co-primary endpoint, demonstrating superior overall survival (OS) compared with standard therapy with Pfizer’s Sutent in intermediate- and poor-risk patients. The combination also met a secondary endpoint of improved OS versus Sutent in all randomized patients.
The showing followed an early peek at data last month that had raised questions about the viability of the combo approach in kidney cancer. The mixed results from that report showed that the combo hit its response-rate endpoint at 41.6%, compared with 26.5% for Pfizer’s Sutent, but narrowly missed its goal of showing the pair could stave off cancer growth better than Sutent did.
Leerink analyst Seamus Fernandez told clients he saw today’s report as a positive rebound from the mixed initial progression-free survival numbers. Leerink researchers believe the overall survival results likely confirm “the durability of the signal seen on PFS,” which is why Fernandez thinks the combo will get an FDA approval, one that he says is “critically important” for growth in Bristol-Myers' shares.
Opdivo is already approved to treat kidney cancer in patients who’ve failed after one round of treatment, and that population accounted for 15% to 20% of the drug’s $768 million in second-quarter sales.
BMS shares moved up more than 3% in early trading after the company reported the data. The full data are slated to be released on Sunday at the European Society for Medical Oncology conference in Madrid.
The new kidney cancer study is just one of several in which Opdivo and Yervoy are being tested together. The two meds are already approved to treat melanoma together, and BMS is awaiting more data on the pairing in a variety of other cancers, including lung cancer.
Other drugmakers are also going the combo route, including Merck & Co. with Opdivo’s key rival, Keytruda. In fact, the new data add to a cache of results for PD-1/PD-L1 checkpoint inhibitors in combination with two different types of meds, CTLA4 drugs like Yervoy and chemotherapy drugs. So far, the chemo combos—including a pairing with Merck & Co.’s Keytruda—have put up the stronger results; Keytruda’s chemo combo already has a first-line lung cancer approval. But with the CTLA4 data still rolling in, that could change.
In a recent development, the FDA has put a partial hold on three studies testing Opdivo alongside Celgene’s Revlimid (lenalidomide) or Pomalyst (pomalidomide) in some cases of multiple myeloma after an elevated risk of death forced the halting of trials of those drugs with Keytruda.