Boehringer goes earlier than Bayer

In the HER2-mutant non-small cell lung cancer battle, Boehringer has already beaten its rival Bayer to the market – and now it’s pushing its drug, Hernexeos, into an adjuvant setting that Bayer is yet to move into with its project, sevabertinib.

According to a recent listing on clinicaltrials.gov, the Beamion Lung-3 trial, due to start in December, will test Hernexeos, versus investigator’s choice of PD-(L)1 inhibitor, in patients with HER2m NSCLC following surgery. The primary endpoint is disease-free survival.

Hernexeos got FDA accelerated approved in August for second-line HER2m NSCLC, based on the phase 1 Beamion Lung-1 trial. Bayer, meanwhile, is awaiting a decision on sevabertinib (BAY2927088) in the same setting, based on the phase 1/2 Soho-1 study. This verdict could come as early as November, although it’s unclear if this could be delayed by the US government shutdown.

First-line battle

A battle is also approaching in first-line HER2m NSCLC, where confirmatory trials of both agents are under way. Boehringer might have an edge here, too: its Beamion Lung-2 study is set to complete in November 2026, while Bayer’s Soho-2 trial has a primary completion date of April 2027 – the latter had once been slated to end in June 2026.

And there will soon be an indication of how Hernexeos could fare in Beamion Lung-2: the upcoming ESMO meeting is set to feature data from a first-line cohort of Beamion Lung-1 in a late-breaking presentation.

Sevabertinib is also on the ESMO agenda, with more results from Soho-2 being presented a late-breaker – but the abstract title doesn't give away much, so it’s difficult to say how these might differ from results already reported, from second-line patients in cohort D. 

Around 2-4% of NSCLC patients are thought to harbour HER2-activation mutations; additionally, Boehringer has ambitions in patients with wild-type, but overexpressed or amplified HER2. 

It's now become clear that the group also hopes to move Hernexeos much earlier in the treatment paradigm – it’ll be interesting to see if Bayer follows suit.

Phase 3 trials of Hernexeos (zongertinib) in HER2m NSCLC

Source: OncologyPipeline & clinicaltrials.gov.