The month ahead: December’s upcoming events

It might be nearly the end of the year, but the biotech schedule shows no signs of letting up. Several oncology meetings will take place in December, including ASH, the San Antonio Breast Cancer Symposium (SABCS) and a couple of ESMO spinoffs.

Various projects are also awaiting FDA approval decisions next month. BeiGene is due a stomach cancer reckoning, while a green light might come for subcutaneous formulations of two drugs approved in IV form: Bristol Myers Squibb’s Opdivo and Johnson & Johnson’s Rybrevant.

Better than IV?

It’s unclear exactly when SC Rybrevant’s PDUFA date is – J&J merely disclosed in June that it had submitted the file to the FDA, and in August that this had received priority review. The filing is based on Paloma-3, which suggested that SC Rybrevant was more efficacious than the intravenous version.

BeiGene, meanwhile, looks likely to get the nod for its PD-1 inhibitor Tevimbra in first-line gastric/gastroesophageal junction cancers and oesophageal squamous cell carcinoma (the latter use originally had a July 2024 PDUFA, but this was missed because of a September adcom).

One question, though, to what extent the FDA will limit the drug to PD-L1 expressers. A clue could come from Wednesday’s EU nod, in patients with a tumour area positivity (TAP) score of ≥5%.

One decision that won’t come in December involves AstraZeneca and Daiichi’s TROP2-targeting ADC datopotamab deruxtecan. The project had been due a decision by the end of the year in second-line non-squamous NSCLC, but in mid-November Astra pulled its filing, and is now focused on EGFR-mutant NSCLC.

Astra made no mention of any change in its EU strategy, meaning that dato-dxd might still be due an opinion from the CHMP next month in second-line lung, as well as in relapsed breast cancer.

SABCS & ASH

Breast cancer will be a focus around the middle of the month, with SABCS. A big draw will be results from Lilly’s Ember-3 trial of the SERD imlunestrant, in second-line ER-positive, HER2-negative breast cancer, toplined positive last month.

The meeting will also see data on the company’s PI3K alpha inhibitors: the now abandoned LOXO-783, and the preclinical-stage next-generation asset LY4045004.

And Pfizer will present more data on its KAT6 inhibitor, PF-07248144, which impressed at this year's ASCO meeting. 

First, though, will be the haematology meeting ASH. Highlights this year are set to include data on Arcellx and Gilead’s BCMA-targeting Car-T contender anitocabtagene autoleucel, Incyte’s Monjuvi, and menin inhibitors from Syndax, Kura and J&J. Still, this year’s conference looks like being more subdued than other editions.

There will also be several investor meetings at the start of the month, as well as R&D days from Takeda and Zymeworks. Meanwhile, Affimed will present an update on 17 December on its anti-EGFR x CD16A bispecific antibody AFM24, from the AFM-102 trial in late-line NSCLC, where it's being tested alongside Tecentriq.

Data are expected on response rates in an EGFR wild-type population; PFS results in this cohort, and data in EGFR mutants, are due next year. Affimed has just €24m in cash, enough to fund it until the end of 2025.

December’s upcoming events

Source: OncologyPipeline.