The month ahead: September’s upcoming events

The summer holidays are almost over, and biopharma’s oncology sector will be looking ahead to a busy September, with conferences returning with a bang. ESMO is the highlight, but September will also see the World Lung and SOHO congresses, as well as various investment bank shindigs.

Several projects are awaiting an approval decision from the FDA, perhaps most notably Roche’s subcutaneous version of Tecentriq, which missed its September 2023 PDUFA date owing to manufacturing problems. And important readouts are due by the end of the third quarter for Gritstone’s neoantigen immunotherapy Granite and Black Diamond’s fourth-generation EGFR inhibitor BDTX-1535.

ESMO and World Lung

ESMO has arguably become as important as its US counterpart, ASCO; highlights from this year’s European meeting include data on GSK and Iteos’s anti-TIGIT MAb belrestotug, Amgen’s PRMT5 inhibitor AMG 193 (which disappointed last year), and a KRAS G12D degrader from Astellas.

However, the conference perhaps lacks the wow factor of previous years – something that might be down to its proximity to ASCO. In 2023 ESMO was held in October.

Meanwhile, the main draw at the World Conference on Lung Cancer is the Chinese Harmoni-2 trial of Summit and Akeso’s anti-PD-1 x VEGF bispecific ivonescimab. The companies made waves when they reported that study’s success, which tests ivonescimab versus Keytruda in first-line NSCLC, on the eve of ASCO.

The Society of Hematologic Oncology (SOHO) conference will see data from Syros’s failed Select-AML-1 study of tamibarotene, and the Felix trial of Autolus’s obecabtagene autoleucel (obe-cel), which is awaiting an FDA approval decision in November.

PDUFAs and PD-1 adcom

In the nearer term, September PDUFA dates loom for the aforementioned subcutaneous Tecentriq, which is still ahead of the competition despite its previous slip.

Also delayed is Novartis’s Kisqali in adjuvant breast cancer, with a decision on the Natalee trial recently pushed back by three months; a verdict is now expected by the end of the third quarter.

Sanofi will be hoping for a smoother ride with its anti-CD38 MAb Sarclisa, which has long lagged Genmab and Johnson & Johnson’s Darzalex in terms of sales. Sanofi could steal a march on its rival with approval in first-line transplant-ineligible multiple myeloma in combination with Velcade, Revlimid and dexamethasone (VRD).

However, Darzalex might not be too far behind here, with J&J recently revealing that its analogous Cepheus trial had met its primary endpoint.

Merck & Co’s Keytruda might add to its already impressive roster of approvals; the company is seeking a nod in first-line mesothelioma, based on an investigator-sponsored trial. Bristol Myers Squibb’s Opdivo/Yervoy combo was approved in this setting in 2020, while AstraZeneca is carrying out the Evolve-Meso phase 3 first-line mesothelioma trial of volrustomig, its anti-PD-1 x CTLA4 bispecific.

Another big event for checkpoint inhibitors is approaching, with an FDA advisory committee set to discuss whether the approvals of anti-PD-1 antibodies in first-line gastric cancers approvals should be restricted to PD-L1 expressers.

Existing approvals of Keytruda and Opdivo could be affected, as could be two settings in which BeiGgene's PD-1 latecomer Tevimbra is awaiting FDA decisions. 

Gritstone’s second chance

Finally, clinical readouts due in the third quarter include what could be a last chance for Gritstone, which has been in the doldrums since reporting disappointing phase 2 data with its neoantigen immunotherapy Granite in colorectal cancer earlier this year.

With molecular response results looking lacklustre, Gritstone highlighted early PFS trends it deemed favourable. Mature PFS results, due this quarter, could be make or break for the company, which has $62m in cash and a market cap of just $58m.

Investor hopes are higher for Black Diamond, which this quarter will release initial phase 2 data on its fourth-generation EGFR inhibitor BDTX-1535 in second and third-line NSCLC patients with non-classical EGFR mutations.

The project is designed to hit mutations that AstraZeneca’s Tagrisso, a third-generation drug, does not. The phase 1 portion of the same trial previously showed a 29% ORR among 21 NSCLC patients on BDTX-1535 who had received an EGFR inhibitor, usually Tagrisso.

September’s upcoming events

Source: OncologyPipeline.