The month ahead: April’s upcoming events

Spring is here, and conference season is picking up. April will feature the AACR meeting, the highlight from which could be first-in-human data with Merck & Co’s MK-2010, the anti-PD-1 x VEGF antibody it licensed for $588m up front from LaNova.

The month ahead could also see several FDA approval decisions. A big one will concern Replimune’s oncolytic virus candidate vusolimogene oderparepvec, which the agency knocked back in July; verdicts are also expected on a subcutaneous version of Sanofi’s Darzalex rival Sarclisa, and Orca’s allogeneic T-cell therapy Orca-T, which that group hopes will provide an alternative to conventional allogeneic haematopoietic stem cell transplant.

Meanwhile, several upcoming data readouts have been delayed, and some of these are now expected in April.

Not adequate?

The FDA handed Replimune a CRL in July; the group had been seeking accelerated approval for a vuso-vec/Opdivo combo in post-PD-(L)1 melanoma. At the time, the agency said the supporting phase 1/2 Ignyte trial wasn’t “adequate and well controlled”, as well as raising questions about the confirmatory Ignyte-3 study.

However, in October, the FDA accepted Replimune’s resubmitted BLA – according to the company, additional information, data and analyses were included, although details are unclear. It shouldn’t be long before it becomes apparent whether anything meaningful has changed.

Orca will be hoping for less drama with Orca-T, an engineered cell preparation derived from partially matched donors, which prevailed in the Precision-T trial. Still, there are questions about the study’s control arm, because this didn't use post-transplant cyclophosphamide, the so-called Baltimore regimen, a recently emerging standard of care for partially matched transplants.  

Sanofi is banking on a big jump in sales for Sarclisa if it can get a subcutaneous version approved, based on the Iraklia trial. In a good omen for the group, the EU’s CHMP just recommended the new formulation. Sarclisa sold €588m in 2025, versus $14.4bn for Johnson & Johnson and Genmab’s Darzalex, which has been available in an SC formulation since 2020.

Some other FDA decisions, which had been hoped for earlier, might also emerge in April. AstraZeneca’s oral SERD camizestrant is due a verdict in the first half in patients who develop an ESR1 mutation during first-line therapy with CDK4/6 and aromatase inhibitors, but before formal progression.

And a ruling on AbbVie’s ImmunoGen-originated anti-CD123 ADC pivekimab sunirine in the rare cancer type blastic plasmacytoid dendritic cell neoplasms had been estimated for March, but hasn’t yet come.

Data delays

Meanwhile, various readouts have been recently pushed back to April, including results with Compass Therapeutics’ DLL4 x VEGF-targeting antibody tovecimig in second-line biliary tract cancer, and Ideaya’s pan-PKC inhibitor darovasertib in first-line HLA-A2-negative metastatic uveal melanoma.

Both datasets had previously been expected late in the first quarter.

Tovecimig’s phase 2/3 Companion-002 trial is due to yield data on key secondary endpoints of progression-free and overall survival; Compass already reported on overall response rate, the primary outcome, last year. A BLA filing is expected in the second half – assuming the upcoming readout is positive.

Meanwhile, the phase 2/3 Optimum-02 study of Ideaya’s darovasertib had once been expected to yield PFS data, to support an accelerated approval application, by year-end 2025 – but this was delayed until Q1 2026, before the latest pushback. Ideaya said during its fourth-quarter earnings in March that the trial’s database lock is projected in the first half of April, followed by the top-line data analysis “thereafter”.

Other delayed studies include the Furvent trial of Arrivent’s EGFR inhibitor firmonertinib in first-line NSCLC with EGFR exon 20 insertion mutations, which is now due to yield data in mid-2026, from “early 2026” previously.

Elsewhere, Allogene is expecting a big test for its allogeneic Car-T cemacabtagene ansegedleucel, with a first futility analysis from the Alpha-3 trial due in April. It had once been expected in mid-2025.

April’s upcoming events

Source: OncologyPipeline.