NEW YORK – Bristol Myers Squibb on Wednesday reported third quarter sales of $84 million for Opdualag (nivolumab and relatlimab) following its launch earlier this year as first-line treatment for unresectable or advanced melanoma.
Opdualag sales grew 45 percent over the previous quarter for estimated annualized sales of approximately $350 million, according to BMS CFO David Elkins. BMS's share in first-line melanoma is in the mid-to-high teens with use of Opdualag coming from PD-1 monotherapy and Opdivo-Yervoy combinations. "We could not be more pleased at the launch of Opdualag," Elkins said in a conference call Wednesday morning.
The company's cell therapy assets, Abecma (idecabtagene vicleucel) and Breyanzi (lisocabtagene maraleucel) racked up $107 million and $44 million in revenues, respectively. Sales of the multiple myeloma CAR T-cell therapy Abecma represented 59 percent growth compared to the third quarter of 2021 and 22 percent over the second quarter of 2022. Breyanzi, a CAR T-cell therapy marketed for large B-cell lymphoma, beat its 2021 third quarter sales by 50 percent. Elkins noted that its sales growth was driven by strong demand, offset by timing of patient infusions, which would carry over to the fourth quarter. Manufacturing capacity limitations have weighed down production of those therapies, but Elkins said BMS is working to increase capacity for both products.
Sales of BMS's checkpoint inhibitors Opdivo (nivolumab) and Yervoy (ipilimumab) were $2.05 billion and $523 million, respectively.
Overall, the company reported $11.22 billion in revenues for the quarter, a decrease of 3 percent compared to the third quarter of last year, driven primarily by loss of exclusivity of its multiple myeloma drug Revlimid (lenalidomide). US revenues climbed 9 percent to $7.9 billion, while international revenues decreased 24 percent to $3.3 billion.
BMS posted net earnings of $1.61 billion, or $.75 per share, versus a profit of $1.55 billion, or $.69 per share, for Q3 2021. It's non-GAAP EPS for Q3 2022 was $1.99 compared to $1.93 for the prior-year period.
The company is addressing decreasing revenues by advancing a diversified portfolio of new drugs, including repotrectinib, a candidate for ROS1-positive advanced non-small cell lung cancer, which the firm gained with the acquisition of Turning Point Therapeutics. BMS completed that acquisition in August, purchasing 84 percent of the smaller company's stock for a total of $3.18 billion. Repotrectinib is expected to launch in the second half of 2023.
Opdualag was approved by the European Commission for patients whose tumors express PD-L1 in fewer than 1 percent of cells based on an exploratory analysis from the Phase II/III RELATIVITY-047 trial pointing to a greater benefit in the biomarker-defined population, whereas the US Food and Drug Administration granted approval regardless of PD-L1 expression.
Meanwhile, a study published today in Nature may further edge Opdualag into the all-comer population. Researchers from MD Anderson Cancer Center found that neoadjuvant therapy with Opdualag cleared all viable tumor material in 57 percent of patients with stage III melanoma in patients whose tumors expressed 1 percent or greater PD-L1. Biomarker analysis also showed that the pathologic response was not correlated with LAG-3 or PD-1 levels in baseline tumor samples.
BMS is continuing to study Opdualag in both all-comer and biomarker-defined patient populations, including mismatch repair-deficient and microsatellite instability-high cancers, plus LAG-3- and PD-L1-expressing tumors. The lack of clarity as to the role of PD-L1 testing in the use of Opdualag has fueled a longstanding debate around the shortcomings of PD-L1 as a biomarker for immunotherapy response.
Elkins said that about 50 to 60 percent of the Opdualag business is coming out of PD-1 monotherapy and 40 to 50 percent from Opdivo-Yervoy combination therapy. "That's slightly higher Opdivo-Yervoy cannibalization in the third quarter than we had anticipated pre-launch, but we expect that to stabilize," said Elkins.
Currently about 20 percent of first-line metastatic melanoma patients are treated with PD-1 monotherapy, and that's "roughly" evenly split between Opdivo and Merck's Keytruda (pembrolizumab), according to Elkins. "The vast majority of the use of this asset in the long run should continue to come from PD-1 monotherapy. Some of that will be Opdivo. Some of that will be from the competitor," said Elkins. "That 20 percent share is the target for us."
In the area of CAR T-cell therapy, BMS is looking forward to capitalizing on clinical trial results showing that Abecma is the first BCMA CAR T-cell therapy to have demonstrated superiority to standard regimens in relapsed or refractory multiple myeloma and compares favorably against Janssen and Legend Biotech's Carvykti (ciltacabtagene autoleucel).
Abecma is approved for patients who have received four or more prior lines of therapy based on results from the Phase II KarMMa clinical trial. However, the Phase III KarMMa-3 trial, carried out in collaboration with 2seventy bio, showed that patients had longer progression-free survival and improved overall response rates with the BCMA-targeted CAR T-cell therapy than those on one of five standard-of-care combination regimens.
The companies have plans to launch a trial in earlier, post-transplant lines of treatment. "We do believe Abecma remains a very differentiated asset, from a safety profile perspective as well as the first CAR T that has data in a randomized Phase III trial showing superiority to the current standard of care," BMS Chief Medical Officer Samit Hirawat said on the conference call.
At the American Society of Hematology annual meeting in December, BMS will present data for its pipeline CAR T-cell program, GPRC5D and new data from the Phase II KarMMa-2 trial establishing proof-of-concept in the post-transplant treatment setting.