The month ahead: July’s upcoming events

Summer is here, but the FDA will be keeping busy throughout July, with five oncology PDUFA dates looming and a few more approval decisions possible. Two of these will involve Regeneron’s troubled T-cell engagers linvoseltamab and odronextamab, and that group will hope for more luck on its second attempts.

Meanwhile, it will become clear whether the Starglo study is strong enough to support Roche’s rival anti-CD20 T-cell engager Columvi in B-cell lymphoma. And GSK’s Blenrep will also get another shot in second-line multiple myeloma, after previously being marketed, then withdrawn, in late-line disease. 

The FDA is also set to rule on Replimune’s oncolytic virus vusolimogene oderparepvec in post-checkpoint inhibitor melanoma, while decisions could come on Dizal’s EGFR inhibitor sunvozertinib and Johnson & Johnson’s bladder cancer hopeful TAR-200.

Investors are also still awaiting verdicts on J&J’s Darzalex in smouldering multiple myeloma, and Lilly’s SERD imlunestrant and non-covalent BTK inhibitor Jaypirca.

And Cogent is facing a big readout for its kinase inhibitor bezuclastinib, a potential rival to Blueprint Medicines’ Ayvakit. Sanofi recently agreed to buy Blueprint for $9.1bn, showing the kind of rewards Cogent could reap if it’s successful. However, a recent $400m debt financing could provide a reason to be cautious.

Several readouts that had been expected in the first half could also slip into July, including the Tropion-Breast02 trial of AstraZeneca and Daiichi’s Datroway in first-line triple-negative breast cancer, and the Costar Lung of GSK’s anti-Tim-3 project cobolimab in post-PD-(L)1 lung cancer.

Regeneron’s double whammy

Regeneron’s linvoseltamab, which targets BCMA, and odronextamab, which hits CD20, both received FDA complete response letters last year: linvoseltamab for manufacturing issues, and odronextamab because its confirmatory trials weren’t sufficiently enrolled.

These issues have apparently been resolved, but the company has already narrowed its ambitions for odronextamab, now focusing solely on third-line follicular lymphoma, having previously additionally sought accelerated approval in the more aggressive setting of diffuse large B-cell lymphoma.

Roche’s Columvi, meanwhile, already has an accelerated nod in third-line B-cell lymphoma; Starglo was supposed to convert that into a full approval, as well as expanding the drug’s use into second-line disease.

On the face of it results looked positive, but a May adcom noted that Starglo’s population was heavily skewed towards Asia, and that US patients did numerically far worse. While Roche claimed during a recent investor day that there was “no evidence” that region and/or race had an impact on treatment outcomes, it was clear that patients in Asia drove the overall positive survival result.

Columvi looks unlikely to be pulled in third-line disease, but the second-line approval is hanging in the balance after the adcom voted eight to one that Starglo’s result wasn't applicable to a US population.

Dreamm come true?

GSK’s BMCA-targeting ADC Blenrep originally got accelerated approval for late-line multiple myeloma in 2020, but was withdrawn in 2023 after failure of the confirmatory Dreamm-3 study. The company is now trying again after positive results in the second-line Dreamm-7 and 8 trials.

Eye toxicity, a known side effect of Blenrep, looks likely to be a big topic at an adcom scheduled for 17 July. A question is whether there will be enough time to return a decision before Blenrep’s PDUFA date of 23 July. Another, if approval comes, is whether Blenrep will have a place in a rapidly changing multiple myeloma market.

Things could be more clear cut for Replimune’s vusolimogene oderparepvec, a rare oncolytic virus success story. That company is gunning for accelerated approval in post-PD-(L)1 inhibitor melanoma, where vuso-vec has produced similar efficacy to Iovance’s approved tumour infiltrating lymphocyte (TIL) therapy Amtagvi, on a cross-trial basis, and could be more convenient.

However, Iovance has struggled to sell Amtagvi, so even if Replimune gets the nod for vuso-vec its hard work might only just be beginning.

Meanwhile, PDUFA dates haven’t been given for Dizal’s sunvozertinib or J&J’s TAR-200, but based on filing disclosures the decisions could come in July. The former is filed for second-line NSCLC with EGFR exon 20 mutations, where J&J’s Rybrevant is already approved.

TAR-200, a gemcitabine-eluting intravesical device, is awaiting a decision in BCG-unresponsive high-risk non-muscle invasive bladder cancer with carcinoma in situ – one of many NMIBC uses that J&J is pursuing. J&J will also kick off earnings season next month.

July’s upcoming events

Source: OncologyPipeline.