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Noted This Week

June 24–30

Bristol Myers Squibb’s (BMS) Juno Therapeutics announced that the FDA approved lisocabtagene maraleucel (liso-cel; Breyanzi) for adults with large B-cell lymphoma (LBCL) who don’t respond to, or relapse within 12 months of, first-line chemotherapy and are not eligible for hematopoietic stem cell transplantation. The drug’s efficacy was evaluated in two trials: In the 184-patient TRANSFORM study, the estimated 1-year event-free survival was 45% in the liso-cel group compared with 24% in the standard therapy group; in the PILOT trial, 54% of the 61 patients who received liso-cel experienced a complete response. Liso-cel was approved with a Risk Evaluation and Mitigation Strategy because of the risk of fatal or life-threatening cytokine release syndrome and neurologic toxicities.

After reviewing 5-year survival results from the DUO trial, the FDA warned of a possible increase in the risk of death with duvelisib (Copiktra; Secura Bio), a PI3K inhibitor, compared with ofatumumab (Arzerra; Genmab/Novartis), an anti-CD20 monoclonal antibody that inhibits B-cell activation. Patients in the trial who received duvelisib also had a higher risk of serious side effects, including infections, diarrhea, lung and intestinal inflammation, skin reactions, and high levels of liver enzymes. Approved in 2018, duvelisib is used to treat adults with chronic lymphocytic leukemia or small lymphocytic lymphoma who have previously received at least two other therapies.

Ipsen announced that it will acquire Epizyme, a biopharmaceutical company developing therapies against novel epigenetic targets to treat patients with cancer. Among other assets, Ipsen will gain tazemetostat (Tazverik), a first-in-class EZH2 inhibitor, which is FDA approved to treat certain adults with follicular lymphoma (FL), as well as patients age 16 and older with metastatic or locally advanced inoperable epithelioid sarcoma. The deal is worth approximately $247 million, but milestone payments could increase the value.

Kite announced that the European Commission approved axicabtagene ciloleucel (axi-cel; Yescarta) to treat adults with relapsed/refractory FL after at least three systemic therapies. The approval was based on findings from 75 patients in the single-arm, phase II ZUMA-5 trial who met these conditions. The overall response rate to axi-cel, a CD19-directed chimeric antigen receptor T-cell therapy, was 91%; the complete response rate was 77% after 24 months, and the median duration of response was 38.6 months.

Study findings published in the Journal of Clinical Oncology indicate that PSA-based endpoints should not be used as surrogates for overall survival (OS) in men whose prostate cancer recurs following surgery (J Clin Oncol 2022 Jun 23 [Epub ahead of print]). Rather, this new analysis of the NRG Oncology/RTOG 9601 trial suggests that metastasis-free survival (MFS) is currently the best surrogate endpoint in this group of patients. MFS has been considered a valid surrogate for OS in men treated for localized prostate cancer.

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