Boehringer’s oral HER2 drug awaits FDA decision in third quarter

GERMANY – Boehringer Ingelheim is moving closer to bringing a new oral treatment for HER2-mutated lung cancer to the market, as the FDA has begun a priority review of its drug, zongertinib.

If approved, it would become the first oral, targeted therapy in the U.S. for patients with unresectable or metastatic non-small cell lung cancer (NSCLC) with HER2 mutations who have already undergone systemic therapy.

A race against Bayer

Boehringer is competing closely with Bayer, which is also developing an oral HER2 drug for the same type of lung cancer.

While Bayer’s BAY 2927088 has shown promising results in clinical trials, Boehringer has taken the lead, with its FDA submission already under review.

Both companies are conducting phase 3 trials to expand their drug’s use and confirm long-term efficacy, but Bayer has yet to announce a regulatory filing for its candidate in any market.

Promising clinical results

The FDA’s decision on zongertinib is based on findings from the Beamion LUNG-1 trial, presented at the World Conference on Lung Cancer (WCLC) last September.

The study reported a 71% objective response rate (ORR), indicating strong potential for effectiveness.

Expressing optimism about the drug’s impact, Shashank Deshpande, head of human pharma at Boehringer, stated: “We believe zongertinib has the potential to transform the care of previously treated patients with HER2-mutant advanced NSCLC and are hopeful about the continued research in other tumor types and lines of therapy.“

He also emphasized that the priority review reflects the urgent need for better treatment options in this patient population.

A Unique addition to HER2 treatments

Currently, the only FDA-approved HER2-targeted treatment for this type of lung cancer is Enhertu (trastuzumab deruxtecan), developed by AstraZeneca and Daiichi Sankyo. Enhertu is administered as an intravenous infusion every three weeks. While Pfizer’s Tukysa (tucatinib) is an oral HER2 drug, it is only approved for HER2-positive breast and colorectal cancers.

Other attempts to introduce an oral HER2-targeted therapy for lung cancer have faced challenges. For instance, Spectrum Pharmaceuticals’ poziotinib was rejected by the FDA in 2022 as a second-line treatment for NSCLC with HER2 exon 20 insertions, the most common HER2 mutation.

A step forward for patients

Boehringer estimates that HER2 mutations occur in about 2% to 4% of NSCLC cases, and these mutations are linked to a poor prognosis and a higher risk of brain metastases.

If zongertinib receives FDA approval, it could offer a more accessible and convenient treatment option for patients with limited alternatives.

With the FDA’s priority review process speeding up the evaluation, a final decision is expected by the third quarter of this year, marking an important milestone in HER2-targeted lung cancer treatments.