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 it might 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, so it will be interesting to see if Bayer follows suit.

Phase 3 trials of Hernexeos (zongertinib) in HER2m NSCLC

Source: OncologyPipeline & clinicaltrials.gov.