The month ahead: September’s upcoming events

Biotech investors must be hoping that a new school term will spell a fresh start in a turbulent year, and there will certainly be plenty of activity in September, with a packed meeting schedule. World Lung heralds the return of major oncology conferences, and there will also be a slew of investment bank gatherings – including Citi’s aptly named “biopharma back to school” meet-up.

Several projects could also get FDA approval decisions, the most notable being Merck & Co’s subcutaneous version of Keytruda. Meanwhile, a subcutaneous formulation of Roche’s Lunsumio had once been due a verdict in third-line-plus follicular lymphoma by 22 September, but Roche slipped out in its second-quarter earnings presentation that this had been pushed back by three months, without giving a reason for the delay.

IV to SC

Merck is seeking approval for SC Keytruda across all of the drug's current IV solid tumour indications, and a green light is widely expected following positive data from the Keynote-D77 trial, presented at the European Lung Cancer Congress in March.

Merck’s PD-(L)1 rivals Bristol Myers Squibb and Roche already have approved SC checkpoint inhibitors, in Opdivo Qvantig and Tecentriq Hybreza respectively. All three SC anti-PD-(L)1 drugs use modified hyaluronidase, Roche and Bristol having licensed a product called Enhanze from Halozyme, while Merck has rights to Alteogen’s Hybrozyme.

An added twist is that Halozyme claims that its patents are infringed by SC Keytruda, and is seeking a settlement that could give it a new royalty stream. Court hearings are set for next year.

Timings unclear

Timings look less clear for a SC version of Johnson & Johnson’s anti-EGFR x cMET bispecific antibody Rybrevant. That project was knocked back by the FDA last December over manufacturing issues; J&J has since said it has refiled, but it doesn’t disclose PDUFA dates, so a decision could come any time in the second half. SC Rybrevant got EU approval in April.

AstraZeneca could find out if its MEK inhibitor Koselugo can be expanded into adults with neurofibromatosis type 1-associated plexiform neurofibromas. The drug has had FDA go-ahead in children with this rare condition since 2020, and is now facing competition from Merck KGaA’s Gomekli, gained via that group’s acquisition of SpringWorks.

Investors are also still awaiting verdicts on several assets that had been expected in previous months, including J&J and Genmab’s Darzalex in smouldering myeloma and in first-line, transplant-ineligible multiple myeloma; and Lilly’s imlunestrant and Jaypirca, the former in second-line breast cancer, and the latter in second-line CLL.

World Lung

Several scientific conferences are set for September, including the Society of Hematologic Oncology (SOHO) congress and the International Myeloma Society meeting, but the big draw will be the World Conference on Lung Cancer in Barcelona – particularly as this will feature Summit’s global Harmoni second-line NSCLC study of the Akeso-originated anti-PD-1 x VEGF project ivonescimab.

Summit toplined Harmoni in May, with PFS looking good but an interim read of overall survival disappointing. Investors will hope for more positive OS details at World Lung, especially after Akeso just slipped out an OS win in its analogous Chinese trial, Harmoni-A – without revealing any data.

September’s upcoming events

Source: OncologyPipeline.