The month ahead: May’s upcoming events

Sunny days are here again, and so is the annual ASCO meeting. The biggest cancer conference of the year will start at the end of the month, and investors already have a flavour of what’s to come, with the titles released last week.

Meanwhile, there could be several FDA decisions, with verdicts looming for AstraZeneca and Daiichi’s Enhertu in neoadjuvant breast cancer, and Otsuka’s Inqovi in first-line AML ineligible for intensive induction chemotherapy. A ruling on the latter had previously been due in February, but this was delayed by three months, Otsuka disclosed in its fourth-quarter presentation, without saying why.

There are also some upcoming verdicts for which timing is less clear, for example those involving two AstraZeneca projects: its oral SERD camizestrant in an unusual first-line breast cancer setting, and its AKT inhibitor Truqap in the new use of first-line PTEN-deficient hormone-sensitive prostate cancer.

Both got a grilling from an FDA adcom on 30 April, with camizestrant receiving a surprise 6-3 vote against Serena-6, and Truqap being endorsed by seven votes to one. Whether to approve or not now rests with the FDA.

Next gen

And decisions could emerge on BeOne’s next-generation BCL2 inhibitor sonrotoclax in its first potential indication, relapsed/refractory mantle cell lymphoma, and on Roche’s PD-L1 inhibitor Tecentriq in high-risk adjuvant muscle-invasive bladder cancer.

The former will give an indication of whether BeOne is on track to produce a more potent drug than Venclexta, but the more important use for sonrotoclax will be CLL, where the next big readout will be from the front-line Celestial-TNCLL (301) trial, due this year.

The Tecentriq decision, if positive, could herald a new ctDNA-guided approach in bladder cancer. The supporting Imvigor-011 study had surveillance and treatment phases, with the latter focusing on patients with detectable circulating tumour DNA; the hope is that this strategy could spare patients unnecessary therapy.

The trial used Natera’s Signatera assay, which is also under FDA review for use as a companion diagnostic.

ASCO & others

May will see several investor conferences, as well as the ESMO Breast Cancer congress and the annual meeting of the American Society of Gene and Cell Therapy. But the big event will be ASCO.

It’s already been revealed that the plenary sessions will feature the likes of Revolution Medicines’ pan-RAS inhibitor daraxonrasib, and Summit and Akeso’s anti-PD-1 x VEGF project ivonescimab, among others.

The abstract texts will be revealed on 21 May, while late-breakers won’t be made public until the morning of the day of their ASCO presentation.

Meanwhile, new readouts next month could include the Viktoria-1 trial of Celcuity’s PI3K/mTOR inhibitor gedatolisib in second-line breast cancer, specifically in PIK3CA-mutant patients. The study already prevailed in PIK3CA-wild-types, where Celcuity is awaiting an FDA decision by July.

However, one data drop that had been due in early 2026, from Arrivent’s Furvent trial of firmonertinib in first line exon-20 insertion NSCLC, has been pushed back to mid-2026.

May’s upcoming events

Source: OncologyPipeline.