The month ahead: March’s upcoming events

February was a big month for FDA oncology approvals, but March is shaping up to be quieter: decisions are expected on two assets: AbbVie’s ImmunoGen-originated anti-CD123 ADC pivekimab sunirine in the rare cancer type blastic plasmacytoid dendritic cell neoplasms, and Johnson & Johnson’s Tecvayli, alongside Darzalex, in second-line multiple myeloma.

A verdict might also come on AstraZeneca’s oral SERD camizestrant in an unusual breast cancer setting, patients who develop an ESR1 mutation during first-line therapy with CDK4/6 and aromatase inhibitors, but before formal progression. However, the timing of this decision, based on the Serena-6 trial, is unclear, with Astra only specifying it’s expected in the first half.

J&J’s second-line Tecvayli/Darlalex nod, meanwhile, could be imminent – the FDA proactively awarded the combo a commissioner’s national priority voucher (CNPV) in mid-December, a move designed to speed up the review process, and a February approval had been anticipated.

SERD Perseverance

Outside regulatory developments, there are plenty of investor and scientific conferences, and various trial readouts looming.

A big one concerns another oral SERD, Roche’s giredestrant, with the Persevera trial in first-line ER-positive, HER2-negative breast cancer set to yield data in the middle of the first half, the company said during its fourth-quarter earnings call. Results had once been expected last year.

Giredestrant has already prevailed in second-line breast cancer, in Evera – although a recent FDA filing was restricted to the ESR1-mutant population – and in the adjuvant setting in Lidera. Recent readouts have helped increase confidence in the asset, which looked buried after failing the phase 2 Acelera trial.

Persevera has enrolled endocrine therapy-sensitive patients; giredestrant is also in a first-line study in endocrine therapy-resistant patients, called Pionera, with results expected next year.

Furvent believer

Meanwhile, Arrivent could take on J&J’s cMet x EGFR bispecific antibody Rybrevant with its tyrosine kinase inhibitor firmonertinib, should the project convince in the Furvent study. The trial is in a relatively small niche, first-line NSCLC with EGFR exon 20 insertion mutations.

The study had been due to read out last year, but Arrivent has been increasingly focused on NSCLC with PACC (P-loop alpha-c helix compressing) mutations, where it’s now begun the pivotal Alpacca trial.

At the latest update, the Furvent data were due in “early 2026”, so the clock is ticking.

Compass Therapeutics should also see progression-free and overall survival data this quarter from the Companion-002 trial of its DLL4 x VEGF-targeting antibody tovecimig in second-line biliary tract cancer. The study already prevailed on its primary endpoint, overall response rate, but the upcoming results will be needed for a filing.

The survival data were originally expected in the second half of 2025, then were pushed back into the fourth quarter, before the latest delay, due to fewer deaths than anticipated – which might or might not be a good sign for Compass. Investors seem confident, with the group’s stock tripling since the ORR data were reported.

Still, Compass’s $1bn market cap is dwarfed by the $5bn valuation of Celcuity, whose stock jumped last year with the success of its PI3K/mTOR inhibitor gedatolisib in second-line (post-CDK4/6 inhibitor) ER-positive HER2-negative breast cancer patients; specifically in PIK3CA-wild-types.

Now the company hopes to see a benefit in PIK3CA-mutant patients in the same trial, Viktoria-1; data, once expected last year, are due late in the first quarter to the second quarter. A win will be key to a broad label. Gedatolisib is awaiting an FDA verdict in wild-type patients by 17 July.

March’s upcoming events

Source: OncologyPipeline.