The month ahead: May’s remaining events

It might be doom and gloom in the biopharma industry right now, but summer is coming, along with the big oncology conference of the year: ASCO. So far, only the abstract titles have been released, but non-late-breaking abstracts are set to drop on 22 May.

Meanwhile, an FDA approval decision is due for Merck & Co’s Welireg in the rare tumours pheochromocytoma and paraganglioma, and Johnson & Johnson and Genmab’s subcutaneous Darzalex Faspro is awaiting a controversial verdict in a disease precursor, smouldering multiple myeloma.

Other decisions that have been expected for the past couple of months and could come in May involve Darzalex Faspro, again, but in the less contentious setting of first-line, transplant-ineligible multiple myeloma, based on the Cepheus trial; and AbbVie’s telisotuzumab vedotin in relapsed, c-Met overexpressing, EGFR-wildtype, non-squamous NSCLC, based on the Luminosity study.

Rare and smouldering

Pheochromocytoma and paraganglioma are tumours in and around the adrenal glands, but they only affect around two to eight people per million each year, so approval here is unlikely to move the needle for Welireg. Merck gained the drug through the $1bn acquisition of Peloton, and sold $509m of it in 2024, driven by use in renal cancer.

Smouldering multiple myeloma, which is asymptomatic but can lead to full-blown multiple myeloma, is also relatively rare. J&J previously told ApexOnco that it was aiming for a cure by going earlier, although using Darzalex in the precursor disease is controversial because around a third of smouldering patients will never progress to multiple myeloma, so would be exposed to the drug’s side effects in vain.

It could be bad news for J&J and Genmab that Vinay Prasad has just been appointed head of the FDA’s Center for Biologics Evaluation & Research – the Aquila study, on which Darzalex’s filing is based, is one of the many clinical trials he’s slammed for being unethical. though technically it's CDER and not CBER that will be responsible for the Darzalex review.

Nevertheless, it’s just emerged that an FDA advisory committee will convene on 20 May to discuss Darzalex in high-risk smouldering multiple myeloma. 

Also featuring will be Roche’s Columvi in second-line, transplant-ineligible DLBCL (based on the Starglo trial, with a 20 July PDUFA date); UroGen’s UGN-102 in low-grade intermediate-risk non-muscle invasive bladder cancer (based on Envision, 13 June PDUFA date); and Pfizer’s Talzenna plus Xtandi in metastatic castration-resistant prostate cancer. 

Talzenna and Xtandi are already approved for HRR-mutant CRPC, but Pfizer has previously said it hoped to get a nod in all comers based on the Talapro-2 trial; the group hadn’t disclosed a PDUFA date.

The FDA said it was unable to post details of the meeting earlier because of “technical issues”. The agency usually gives a 15-day notice period.

ASCO approaches

As well as the usual investor meetings, several scientific conferences will take place in May, with the biggest being ASCO at the end of the month. AstraZeneca has scored two plenaries, again, with camizestrant's Serena-6 trial and Imfinzi's Matterhorn study, while another plenary will feature the Verify polycythemia vera trial of Protagonist/Takeda's rusfertide.

Late-breaking highlights include the Veritac-2 trial of Arvinas/Pfizer's oestrogen degrader vepdegestrant and the First study, testing GSK’s Jemperli plus Zejula in front-line ovarian cancer – although there are reasons to be cautious about both trials.

A late addition to the late breakers is the Destiny-Breast09 trial of Astra and Daiichi’s Enhertu in first-line HER2-positive metastatic breast cancer; the groups recently announced a win in combination with Roche’s Perjeta.

Amgen’s confirmatory Dellphi-304 trial of its DLL3-targeting T-cell engager Imdelltra will also feature among the late breakers, following topline success last month.

Non-late-breakers of interest include the Komet-001 trial of Kura’s menin inhibitor ziftomenib, and the Arc-20 trial of Arcus’s Welireg rival, the HIF2α inhibitor casdatifan in second-line clear cell renal cancer; monotherapy data from the latter have previously been presented, but this time a Cabometyx combo will be in focus.

The full ASCO abstract texts go public at 5pm Eastern time on 22 May, except for late-breakers, which will go live at 7am Central time the morning of their presentations.

May’s upcoming events

Note: MM=multiple myeloma; Vrd=Velcade, Revlimid & dexamethasone. Source: OncologyPipeline.