The month ahead: April’s upcoming events

Spring is here, and with it the start of the scientific conference season. Opening up proceedings will be the American Association for Cancer Research annual congress – and this year, the meeting will for the first time feature an industry partnering event. While preclinical presentations still feature heavily at AACR, this is yet more confirmation that the conference is now focused on companies as much as on academic institutions.

Meanwhile, in addition to several analyst meetings there could also be readouts on Immutep’s Lag3 fusion protein eftilagimod alpha and GSK/iTeos’s anti-TIGIT Mab belrestotug.

Data from the former’s Tacti-003 trial, in first-line head and neck cancer, are expected imminently, and look likely primarily to involve overall response rate. If results disappoint Immutep could have problems attracting a licensing partner to fund a phase 3 study in first-line non-small cell lung cancer.

TIGIT Galaxy

Timelines are less clear for the Galaxies Lung-201 trial, which tests belrestotug plus GSK’s PD-1 inhibitor Jemperli in first-line PD-L1-high NSCLC. GSK and iTeos are only saying that data are expected in 2024, but these had originally been expected in the third quarter of 2023.

TIGIT, once a popular mechanism, has had various setbacks; most recently, Roche again delayed the final analysis of the eagerly awaited Skyscraper-01 trial of tiragolumab, in first-line PD-L1-high NSCLC, with data now not due until the second half. Meanwhile, Gilead and Arcus have turned away from the PD-L1-high NSCLC setting and are now focused on a chemo-containing triplet in all-comers, a bigger population.

Overall, the omens don’t look great for belrestotug, iTeos’s lead project – but at least the group hasn’t yet started phase 3. 

Beyond clinical readouts, first-quarter earnings season begins this month, with Johnson & Johnson kicking off proceedings on 16 April.

A couple of days later, Adaptimmune is holding an investor day, when it will give the first details of its launch strategy for afami-cel. The MAGE A4-targeting T-cell therapy is to receive an FDA approval decision by 4 August in synovial sarcoma, and the company has said it is not expecting an advisory committee meeting.

And the EMA’s CHMP could rule in April on a couple of projects that have already been knocked back in the US: Astellas’s anti-Claudin18.2 MAb zolbetuximab, and Amgen’s Lumakras, whose confirmatory Codebreak-200 trial drew criticism from the FDA. Investors could also get an early indication on what the US regulator thinks about Novartis’s Natalee trial of Kisqali in adjuvant breast cancer – that project was filed in the fourth quarter of 2023 with a priority review voucher.

April’s upcoming events

Source: OncologyPipeline.