The month ahead: December’s upcoming events

As 2025 reaches its end the oncology conference season is still in full swing. December will see the American Society of Hematology congress, as well as the San Antonio Breast Cancer Symposium, along with various other scientific and investor meetings.

Meanwhile, several projects are awaiting FDA approval decisions, including a subcutaneous formulation of Roche’s anti-CD20 T-cell engager Lunsumio. A verdict had originally been due in September, but this was pushed back to allow the agency time to review additional data.

ASH, SABCS & NACLC 

The highlight of ASH could be the first human data with Kelonia’s in vivo Car-T project KLN-1010. Late-breaking sessions will also feature the Majestec-3 trial of Johnson & Johnson’s Tecvayli and Darzalex combo, and the Bruin CLL-313 study of Lilly’s non-covalent BTK inhibitor Jaypirca in first-line CLL.

At SABCS the big draw will be results from the Lidera trial of Roche’s oral SERD giredestrant in early ER-positive, HER2-negative breast cancer. The Swiss group only toplined the study as positive on 18 November.

The North America Conference on Lung Cancer (NACLC), meanwhile, will see data from the phase 3 Preserve-003 trial of BioNTech’s anti-CTLA-4 MAb gotistobart in second-line squamous NSCLC. The project, which uses a pH-sensitive molecule to avoid autoimmunity-related side effects, is supposedly less toxic than Bristol Myers Squibb’s Yervoy. Still, Preserve-003 went on clinical hold in October 2024, although this was lifted in December.

Readout is also expected from the placebo-controlled portion of the phase 2/3 Ringside trial of Immunome’s gamma secretase inhibitor varegacestat in desmoid tumours. The project could take on Merck KGaA’s Ogsiveo, gained via its $3.9bn acquisition of SpringWorks.

Meanwhile, Cogent will hope to add to recent positive readouts with its KIT inhibitor bezuclastinib, with the phase 2 Apex trial in advanced systemic mastocytosis set to read out in December. There are still questions around liver toxicity with the project.

And Janux will report more data with its masked anti-PSMA T-cell engager JANX007 in metastatic castration-resistant prostate cancer at an investor event. However, this might not shed any more light on that project’s efficacy, given that the results released so far from the phase 1 Engager-PSMA-01 trial have been heavily curated.

Approval decisions

As well as SC Lunsumio, an FDA verdict is due on Bristol Myers Squibb’s CD19-targeting Car-T Breyanzi in the new use of relapsed/refractory marginal zone lymphoma. The filing is based on the MZL cohort of the phase 2 Transcend FL trial, which found a 96% ORR.

J&J’s Akeega, a fixed-dose combination of the PARP inhibitor niraparib (branded Zejula) and abiraterone (branded Zytiga), is also awaiting a decision in metastatic castrate-sensitive prostate cancer. The company hasn’t disclosed a PDUFA date, but said in July that it had submitted an application to the FDA.

December’s upcoming events

Source: OncologyPipeline.