Hernexeos beats Hyrnuo to the front line
It took a couple of months longer than expected, but Boehringer Ingelheim has managed to negotiate a new super-fast pathway to secure US approval of its HER2 inhibitor Hernexeos in HER2-mutated lung cancer, now in the front line. The drug already had a green light in pretreated patients, but Boehringer used the commissioner’s national priority voucher (CNPV) programme for a first-line filing; both settings are backed by response rate data from the Beamion Lung-1 study, and both are for now approved on an accelerated basis. The green light means that Boehringer’s first-line skirmish against Bayer’s HER2 inhibitor rival Hyrnuo has gone in Hernexeos’s favour; though Hyrnuo has put up similarly promising first-line data to Hernexeos, Bayer hasn’t revealed plans for a front-line filing. A CNPV shortens FDA review time from 10-12 months to just one or two months, but in the event the FDA pushed back a decision on Hernexeos from December to February. Not all has gone smoothly here, at least outside oncology: Disc Medicine filed bitopertin under the CNPV pathway for erythropoietic protoporphyria, but was recently slapped with a complete-response letter.
Beamion Lung-1 data backing Hernexeos accelerated approvals
| Patient n | ORR | CR rate | |
|---|---|---|---|
| Relapsed HER2m NSCLC | 71 | 75% | 6% |
| Relapsed (post HER2 ADC) HER2m NSCLC | 44 | 44% | 2% |
| 1st-line HER2m NSCLC | 72 | 76% | 8% |
Source: prescribing information & NEJM.
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