Christmas oncology roundup

The quiet period around the Christmas holidays often provides a neat opportunity for companies to release negative news that they perhaps don’t want to receive too much publicity, and so it proved in 2025, with Genmab quietly discontinuing the 4-1BB co-stimulated anti-PD-L1 project acasunlimab.

The days between Christmas and the New Year also saw Verastem axe its RAF/MEK inhibitor avutometinib, and Inovio proceed with an accelerated approval filing for an immunotherapy that the FDA has specifically said doesn’t qualify for accelerated approval. investors might receive these two moves with little more than a shrug, but the same might not be said for acasunlimab.

Genmab’s admission on 29 December that acasunlimab is a dud calls into question the company’s decision to push the molecule into the phase 3 Abbil1ty NSCLC-06 study in November 2024 – just three months after BioNTech had called time on the project and handed it back to Genmab. The scrapping of that deal itself came just months after BioNTech itself had played up acasunlimab’s potential.

Genmab didn’t cite any specific clinical data as backing its discontinuation, saying that the decision was made as part of a “strategic focus on the most value-creating opportunities ... and following a thorough assessment of the evolving competitive landscape”.

31 December:

There was better news two days later from China’s Suzhou Zelgen, which secured $100m up front from AbbVie for ex-China rights to alveltamig, a biparatopic anti-DLL3 x DLL3 T-cell engager that recently entered phase 3. The deal emerged via a Hong Kong regulatory filing and wasn’t announced by AbbVie, which might be keeping a low profile on DLL-3 – the target of its notoriously doomed Stemcentrx-derived ADC, rovalpituzumab tesirine.

29 December:

On the day of acasunlimab’s discontinuation Verastem scrapped the Ramp 203 trial of avutometinib, marking the end of this project as monotherapy, to focus instead on its GenFleet-derived KRAS G12D inhibitor VS-7375/GFH375. Avutometinib, as part of a combination with defactinib, separately gained FDA accelerated approval last May in KRAS-mutated recurrent low-grade serous ovarian cancer under the trade name Avmapki Fakzynja.

Meanwhile, Inovio, whose stock has fallen 98% in five years, announced the filing of its HPV-6-encoding DNA immunotherapy INO-3107 for the precancerous condition recurrent respiratory papillomatosis, seeking accelerated approval based on phase 1 data. While the FDA has accepted this filing, it has said that Inovio hasn’t submitted adequate information to justify eligibility for the accelerated approval pathway.

24 December:

On Christmas Eve Gilead spent $30m to acquire RP-3467, a DNA Polθ inhibitor originated by Repare Therapeutics. This deal is relevant only for the former owners of Repare, which was sold to Xoma last year in a deal that included a contingent value right including 100% of the proceeds from future licensing deals for RP-3467.

22 December:

Two days earlier, Crispr Therapeutics reported a 90% response rate among 10 large B-cell lymphoma patients given a 600 million cell dose of its allogeneic anti-CD19 Car-T therapy zugocaptagene geleucel. Seven of the patients were complete responders.

The project, earlier coded CTX112, previously yielded a 67% response rate among 12 patients given various doses, and represents Crispr’s second shot at this approach, after the discontinuation of the first-generation CTX110 two years ago. There’s still little to go on regarding zugo-cel’s specific regulatory pathway, beyond Crispr highlighting the project’s potential in combination with Lilly’s Jaypirca, and in autoimmune diseases.

19 December:

Notwithstanding the sector’s problems, 2025 turned out to be a good year overall, with the Nasdaq biotechnology index rising over 30%. Still unknown is whether investors have renewed enthusiasm for IPOs – but that will soon be tested, with Aktis Oncology filing to raise $100m. The company has an unusual approach to radiotherapy, and has key backing from Lilly.

One new aspect that’s generated attention is the US commissioner’s national priority voucher (CNPV) scheme, which cuts FDA review time from 10-12 months to just one or two months, and has seen CNPVs awarded to Boehringer Ingelheim’s Hernexeos, GSK’s Jemperli and Revolution’s daraxonrasib. Just before Christmas the FDA granted a CNPV to Merck & Co/Kelun’s sacituzumab tirumotecan, days after giving one to Johnson & Johnson’s Tecvayli, on the strength of ASH data. 

The same day brought some clarity on a bizarre incident four years earlier, when an apparent 2021 San Antonio Breast Cancer Symposium poster relating to Olema’s palazestrant was circulated on social media. At the time Olema said this was an unauthorised and falsified poster image. 

It has now been alleged that this was part of a scheme of “insider trading and market manipulation on a massive scale, using stolen information, falsified data, and fake press releases to mislead investors and enrich” six individuals, including an investment banker. After an FBI investigation the six, who “received illicit profits totalling at least $41m”, have been charged with fraud.