World Lung 2025 preview – late-breakers in focus

The World Conference on Lung Cancer starts next month, and with the titles of most of its presentations now disclosed it's apparent that much attention will fall on Summit's ivonescimab and Nuvalent's zidesamtinib, both of which will star at the meeting's plenary sessions.

Beyond the plenaries, a number of other key presentations remain under wraps, with late-breakers including two trials of SystImmune/Bristol Myers Squibb's izalontamab brengitecan, and one study of an anti-DLL3 ADC Ideaya licensed from HengRui last year. Summit investors will also take note of a rival anti-PD-L1 x VEGF MAb, BioNTech and Bristol Myers Squibb's BNT327, now revealed to have the INN pumitamig.

The pumitamig abstract is already public, with a first-line chemo combo yielding an 87% unconfirmed response rate in 38 first-line extensive-stage SCLC patients. These are said to be the first global data to back up earlier results from a Chinese SCLC study, and to support the phase 3 Rosetta Lung-01 trial, which began in this setting this year.

Harmoni survival

Still, for many the focus remains on Harmoni, the phase 3 ivonescimab study Summit toplined on the eve of this year's ASCO conference, a move received negatively by the markets.

Harmoni, testing a chemo combo versus chemo alone in non-squamous EGFR-mutant lung cancer progressed on a third-generation EGFR inhibitor like Tagrisso, caused concern because despite its hit on PFS it has so far failed to show a positive OS result. Moreover, a US filing isn't possible in the absence of a statistically significant OS benefit.

Harmoni is the first global trial to attempt to show that Akeso's Chinese data, in this case from the Harmoni-A study, weren't a fluke; however, because of a regulatory quirk, most of Harmoni's trial subjects were actually from Harmoni-A. As with other World Lung plenary presentations, only the title of the Harmoni abstract has so far been disclosed.

As such, nothing is known about what more Nuvalent will reveal on its ROS1 inhibitor zidesamtinib, specifically from the Arros-1 trial's kinase inhibitor-pretreated NSCLC cohort. Arros-1 data have previously been presented, including at last year's ESMO and in an update in June.

Selected World Lung 2025 presentations

Source: IASLC.

HengRui's anti-DLL3 ADC SHR-4849 is in focus because Ideaya licensed it for $75m up front last December. The Chinese company's late-breaker features a first-in-human trial, and will presumably offer more backing for the deal, and for Ideaya's plan to start a phase 1 US study during the current quarter.

And much interest still surrounds the EGFR x HER3-targeting ADC izalontamab brengitecan, which Bristol Myers Squibb licensed from SystImmune for $800m up front, and which is now in three Bristol-sponsored pivotal trials, in addition to the 10 Chinese phase 3s being run by SystImmune.

Relatively little human data have been published for this asset, despite its relatively high profile, and with the setbacks Daiichi Sankyo/Merck & Co have had with their monospecific anti-HER3 ADC patritumab deruxtecan much attention will fall on iza-bren's safety profile. The World Lung presentations concern early data with or without Tagrisso in EGFR-mutated lung cancer, but both remain under embargo for now.

World Lung takes place in Barcelona on 5-9 September.