Bristol Myers' Opdivo turns the boat around in Q2 as manufacturing issues haunt CAR-T launch
What a difference a quarter can make.
Stinging from a dip in sales for I/O blockbuster Opdivo last quarter, Bristol Myers Squibb’s top checkpoint inhibitor turned the boat around in Q2, posting 16% growth from the same timeframe in 2020 to $1.91 billion.
On a call with analysts, Bristol Myers execs cited the turnaround to Opdivo’s ongoing gastric cancer launch as well as the inevitable turnaround in prescribing as the Covid-19 pandemic begins to wane. It’s a strong showing for Opdivo despite the fact that the Opdivo combo with CTLA4 inhibitor Yervoy continues turning up red flags.
The drugmaker on Wednesday revealed the Opdivo-Yervoy combo couldn’t extend the lives of patients with gastric cancer, GEJC or esophageal adenocarcinoma in the Phase III CHECKMATE-649 study. The combo’s OS results were a key secondary endpoint for that study, which served up the pivotal data used to approve Opdivo in combination with chemo in those patients.
Yervoy has for years been the focus of raised eyebrows as more and more clinical data from its key Opdivo pairing churns out mixed results. Earlier this month, the combination failed to show clinical benefit in extending the lives of first-line patients with recurrent or metastatic squamous cell carcinoma of the head and neck, according to topline results from the Phase III CHECKMATE-651 study.
The trial tested the duo against what’s known as the EXTREME regimen, a first-line combo of Erbitux, cisplatin/carboplatin and fluorouracil, the drugmaker said. Bristol Myers took a shot at spinning a positive, saying the study data showed a “clear, positive trend towards overall survival” for high expressing PD-L1 positive patients and noting the study’s control arm performed “better than expected based on historical data.”
Even with those results in mind, Yervoy still turned in an up period in Q2, raking in $541 million at a 38% growth clip.
Meanwhile, Bristol Myers is keeping a close eye on its pair of CAR-T launches, Breyanzi and Abecma, with manufacturing bottlenecks already posing a challenge. CCO Chris Boerner admitted on the call that demand for Abecma, the first CAR-T approved to target BCMA in fourth-line or later multiple myeloma patients, has already outstripped the company’s ability to supply the drug.
The key bottleneck is in the viral vectors used to engineer the therapy, Boerner said, and Bristol Myers is working on short- and long-term mitigation plans to increase capacity.
“We’re engaging internally and externally to increase the slots we have available, and that will be our focus for that drug in the coming months,” he said.
Abecma cleared $24 million in sales in its first quarter on the market with Breyanzi taking home $17 million.