Clinical Breyanzi’s case strengthened by Bristol Myers amidst the confrontation...

Breyanzi’s case strengthened by Bristol Myers amidst the confrontation with Gilead

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A year ago when Breyanzi’s second-line LBCL (large B-cell lymphoma) key data was revealed by Bristol Myers Squibb which found that a short follow-up time was a significant weakness in the study. 

Phase 3 TRANSFORM trial saw Breyanzi’s ability to keep LBCL at bay. Results after a median 17.5-month follow-up revealed that it also reduced the chance of death, disease progression, or tumor nonresponse by 64.4%, nearly two-thirds, in comparison to a stem cell transplant standard.

The results were made public at the 2022 annual American Society of Hematology meeting. They nearly corresponded to the 65.1% reduced risk the drug recorded at a TRANSFORM provisional analysis done at a 6.2-month median follow-up.

The latest results were comparable with Gilead’s Yescarta, a rival CAR-T immunotherapy. The results of a median follow-up after over two years called the ZUMA-7 trial revealed that Yescarta reduced the same risk by 60.2%.

The drug by Bristol Myers Squibb also eliminated the signs of cancer in a larger number of patients compared to the control therapy. A longer follow-up also revealed a comparatively better response rate than control therapy, 74% against 43%.

Bristol Myers Squibb’s cell therapy development head Anne Kerber stated that according to the established data, Breyanzi should be a new option in the standard of care for second-line LBCL. She also stated that constant improvements were noticed in all endpoints leaving no room for uncertainty over the drug’s performance.

Even though the 27.6% risk reduction of death was not considered to be statistically significant, Breyanzi displayed the potential in elongating the lives of patients. According to the investigators’ projection, 60.6% of the patients in the control group would be alive after a year and a half, in comparison to 73.1% for the Breyanzi group.

Clinical data shows that Breyanzi could compete with Yescarta, but as of now, multiple factors are hindering the drug from its commercial potential even though it has the advantage of a bigger label than Yescarta.

The front-runner of the cell therapy program at Columbia University Medical Center, Ran Reshef was interviewed in which he revealed that in terms of efficacy he likes both Yescarta and Breyanzi, but gives the edge to the former due to steady turnaround time and better success rate in manufacturing. In the third quarter, Bristol Myers Squibb informed about manufacturing success rate problems. Even though the company notified that the issues no longer prevail, the perceptions of doctors will take time to recover.

Bristol Myers Squibb is facing problems in meeting the CAR-T therapy demand. In July, the company had to push back its timeline for the increased supply of the therapy to the following year. In a July conference call, the CCO (Chief Commercial Officer) Chris Boerner stated that the company’s top priority is to deliver the capacity.

A spokesperson from the company revealed that there has been an increase in the therapy’s production capacity due to an approved suite for viral vector production which is an important factor to deliver cell therapies. The company has facilities for cell therapy in Bothell, Washington as well as Warren and Summit, New Jersey, while another two are projected to be online by 2023 and 2025 in Devens, Massachusetts, and the Netherlands respectively.

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