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BMS Reports Q2 Growth in CAR T-Cell Therapies Despite Manufacturing Hurdles


NEW YORK – Bristol Myers Squibb on Wednesday reported greater uptake of new precision oncology products in Q2 including its CAR T-cell therapies Breyanzi (lisocabtagene maraleucel) and Abecma (idecabtagene vicleucel), despite what the company called "lower-than-expected manufacturing success rates."

Overall, in the second quarter, BMS reported a 2 percent increase in revenues to $11.89 billion from $11.70 billion a year ago. The checkpoint inhibitor Opdivo (nivolumab), BMS's top-selling oncology drug, brought in $2.06 billion in Q2 2022, an 8 percent increase from $1.91 billion in Q2 2021. The other checkpoint inhibitor Yervoy (ipilimumab) saw revenues increase by 3 percent to $525 million from $510 million a year ago.

The CAR T-cell therapies Abecma and Breyanzi entered the market in the US and Europe last year. In Q2 2022, Abecma earned $89 million in revenue, more than triple the revenues of $24 million in Q2 2021 when the drug was approved in the US. Breyanzi Q2 revenues more than doubled to $39 million from $17 million in Q2 2021, which was also the first quarter that the drug entered the market.

While BMS's cell therapies helped drive the rapid revenue growth within its new product portfolio, CFO David Elkins noted on a call with investors on Wednesday that manufacturing capacity continues to limit supply of both products. The company is focused on increasing capacity and adding manufacturing sites for these drugs as demand increases.

In Q2, Breyanzi nabbed its second approval in the US as a second-line treatment for relapsed or refractory large B-cell lymphoma. The drug was previously approved early last year in the US and in Europe as a third-line treatment for patients with relapsed or refractory large B-cell lymphoma.

"[Breyanzi] sales were impacted by lower-than-expected manufacturing success rates, which now have been addressed," Elkins said. "We are very pleased to have received a differentiated, broad second-line label in large B-cell lymphoma patients. We are working hard and investing to expand capacity early next year to enable uptake for this indication."

Manufacturing hurdles aside, BMS has high hopes for Breyanzi over the long term. BMS CEO Giovanni Caforio said the latest approval for Breyanzi in the second-line setting "further strengthens our view of [the drug] as a key growth driver for the company, with over $3 billion in non-risk adjusted revenue potential in 2029."

"With this approval, Breyanzi now has the broadest patient eligibility of any CAR T-cell therapy in relapsed or refractory LBCL," he added.

Abecma was approved for patients with relapsed or refractory multiple myeloma who have previously received at least four lines of treatment in the US in March 2021. European regulators approved the same indication in August 2021.

"In cell therapy, you have to stay focused on operational issues, and we are continuing to stay focused on improving turnaround time," said Chris Boerner, chief commercialization officer at BMS. "What I would say is most critical for us at this stage in the launch for both of Abecma and Breyanzi is to continue to be focused on vector supply and drug product supply, [and] to continue to increase that."

Another new drug contributing positively to Q2 revenues was BMS's third immunotherapy product, Opdualag, a combination of Opdivo and the LAG3 inhibitor relatlimab. In March, the US Food and Drug Administration approved the drug for an all-comer population of adult and pediatric advanced melanoma patients. In Q2, Opdualag earned $58 million in sales.

However, last week, the European Medicine Agency's Committee for Medicinal Products for Human Use recommended Opdualag for a biomarker-defined melanoma population. The regulator recommended the drug as a first-line treatment for advanced melanoma patients whose tumors express PD-L1 in fewer than 1 percent of cells.

"The robust demand for Opdualag has mainly been in line with our strategy of taking share from PD-1 monotherapy and, as expected, some use in place of the Opdivo-Yervoy combination" in melanoma, Elkins said. "Internationally, we are pleased with the recent CHMP positive opinion in Europe and look forward to realizing Opdualag's potential to be a new standard of care for patients with metastatic melanoma around the world."

BMS executives noted that Opdivo sales in melanoma were "partially offset" by the Opdualag approval. The company is studying Opdualag in some of the same indications that Opdivo is already approved in, such as colorectal and lung cancer, according to Caforio.

"We look at Opdualag as an opportunity to provide durability to our immuno-oncology franchise, and assuming continued successful development, there is clearly a potential for Opdualag to play a meaningful part of the current revenue space," Caforio said.

The company has projected that Opdualag could earn more than $4 billion in revenue at peak sales in 2029, around the same time that Opdivo will lose exclusivity. Opdivo's first patent claims are slated to expire in 2027.

Looking to the second half of the year, BMS expects to close its $4.1 billion acquisition of Turning Point Therapeutics in Q3. The deal will bring Turning Point's lead candidate, repotrectinib, which is being studied in ROS1-positive advanced NSCLC patients. The firm expects repotrectinib will garner approval and launch in the US in this indication in the second half of 2023. If successfully launched, repotrectinib will be another option for ROS1-positive NSCLC alongside Pfizer's Xalkori (crizotinib) and Genentech's Rozlytrek (entrectinib).