The month ahead: February’s upcoming events

February brings the promise of longer, lighter days – and several potential FDA approvals. Chief among these could be quick nods for Johnson & Johnson’s Tecvayli/Darzalex combo in second-line multiple myeloma, and Boehringer’s Hernexeos in first-line HER2-mutant NSCLC – although the decision on the latter has reportedly been delayed.

Elsewhere, scientific conferences are back in full swing, with the pick of the bunch being the AACR Immuno-Oncology conference and the ASCO genitourinary cancers symposium. Several trial readouts could also come soon.

Priority vouchers

The decision on Tecvayli plus Darzalex will be based on the Majestec-3 trial, which wowed at last year’s ASH meeting. Notably, the FDA proactively awarded the combo a commissioner’s national priority voucher (CNPV) in mid-December, a scheme designed to speed up the review process, and although the exact timing of a decision is unclear the aim is a one to two-month turnaround.

Hernexeos has also been awarded a CNPV, and a ruling in the first-line setting had looked possible last year – although Reuters reported a couple of weeks ago that this decision had been pushed back to mid-February.

Other February FDA verdicts could concern Keytruda plus chemo (with or without Avastin) in platinum-resistant ovarian cancer, based on the Keynote-B96 trial; and Gilead’s CD19-targeting Car-T Yescarta in the presumably niche use of primary CNS lymphoma, based on an investigator-sponsored study.

A decision could also come on Taiho’s Inqovi, a combination of the chemotherapy decitabine and the cytidine deaminase inhibitor cedazuridine, for a new use, first-line AML ineligible for intensive induction chemotherapy. Inqovi is currently approved for myelodysplastic syndromes and chronic myelomonocytic leukaemia.

Readouts

Several trial readouts have also been promised in the early part of 2026. ArriVent expects data with its EGFR inhibitor firmonertinib, from the Furvent trial in first-line NSCLC with EGFR exon 20 insertion mutations, while BioNTech could have an update with its Roche-partnered personalised neoantigen candidate autogene cevumeran in adjuvant colorectal cancer. 

The German group disclosed last year that the phase 2 BNT122-01 trial had crossed the boundary for futility; however, as the data were immature, the study continued.

OnKure could give an early hint of whether there’s a future in its mutant-selective approach to PI3Kα inhibition, with data from a phase 1 trial of OKI-219 due this quarter. After Lilly walked away from a mutant-selective project there are some doubts about this strategy.

And there could also be data from the much-delayed confirmatory Celestimo trial of Roche’s CD20-targeting T-cell engager Lunsumio in second-line follicular lymphoma; the drug currently has accelerated US approval in third-line disease. Readout of Celestimo was last year pushed back from 2025 to 2026, but the study had once been expected to yield data in 2023. A subcutaneous version of Lunsumio got an accelerated FDA nod in December.

February’s upcoming events

Note: CNPV=commissioner's national priority review voucher. Source: OncologyPipeline.