The month ahead: February’s upcoming events

February might be the shortest month of the year, but there’s still plenty going on in the oncology world. As well as the usual investor meetings, there will also be the ASCO Genitourinary Cancers symposium and a new kid on the conference block, the AACR IO meeting.

Approval decisions are due on two projects, Ono’s vimseltinib and SpringWorks’ mirdametinib, both in relatively small niches. And pivotal data could also come in February from Pfizer and Arvinas’s oral SERD vepdegestrant in second-line breast cancer; these had once been expected last year.

PDUFAs

February could see Ono secure approval for vimseltinib, the CSF-1R inhibitor gained via last year’s $2.4bn purchase of Deciphera, in tenosynovial giant cell tumour (TGCT). However, only around 9,000 US patients have TGCT, and Daiichi Sankyo’s CSF-1R/Kit/Flt3 inhibitor Turalio is already approved, albeit with a black box warning of liver toxicity.

Merck KGaA could also soon be challenging here with its Abbisko-originated CSF-1R contender pimicotinib, which looks to have an edge over vimseltinib on efficacy and safety on a cross-trial basis.

Meanwhile, SpringWorks could get its second FDA thumbs up, with a decision due on its MEK inhibitor mirdametinib (proposed trade name Gomekli) in plexiform neurofibromas caused by the genetic condition neurofibromatosis type 1. These nerve tumours are benign but can cause severe disfigurement and pain. There are around 40,000 US patients with NF1-PN.

No drugs are currently approved for adults; AstraZeneca’s rival MEK inhibitor Koselugo is indicated for children, but comes with warnings of cardiomyopathy and ocular, GI and skin toxicities. The drug is given in capsule form, limiting its use in young children or those with difficulty swallowing.

Mirdametinib, meanwhile, is an oral suspension. However, SpringWorks’ ReNeu trial found ORRs of 41% in adults and 52% in children – less than the 66% ORR in children in Koselugo’s Sprint trial.

SERD is the word

At last year’s Jefferies London healthcare conference Arvinas disclosed that data from vepdegestrant’s second-line Veritac-2 trial had been pushed back to the first quarter of 2025, “likely February”. Results had previously been expected in the second half of 2024.

Arvinas hopes that vepdegestrant could have utility in both ESR1-mutant and wild-type patients; oral SERDs have so far tended to only show a benefit in the former. The study’s primary endpoints are PFS in the ESR1m and intent-to-treat populations.

The latest SERD to disappoint was Lilly’s imlunestrant, but that group’s Ember-3 trial was tough to interpret, enrolling both CDK4/6 naive and experienced patients; Veritac-2 only includes CDK4/6-experienced subjects.

Arvinas is also eyeing first-line breast cancer, and here it recently disclosed plans to test vepdegestrant alongside Pfizer’s CDK4 inhibitor atirmociclib.

Another phase 3 readout due in early 2025 involves Amgen’s bemarituzumab, which came via the $2bn acquisition of Five Prime and is licensed to Zai Lab in greater China. The Fortitude-101 study tests the anti-FGFR2b MAb plus chemo, versus chemo alone, in first-line FGFR2b-overexpressing gastric and gastro-oesophageal cancers.

The Fortitude-102 trial, evaluating a bemarituzumab/ Opdivo/chemo triplet in gastric cancer, is set to yield data later this year.

Results could also come this month with Kura’s menin inhibitor ziftomenib, Allogene’s allogeneic CD19 Car-T cemacabtagene ansegedleucel, and MacroGenics’ B7-H3-targeting ADC vobra-duo (all previewed in January’s round-up). Innate Pharma is also set to give more details on its Nectin-4 ADC IPH4502, which recently went into the clinic.

February’s upcoming events

Source: OncologyPipeline.