Zongertinib

Bayer's Hyrnuo won an accelerated approval based on its tumor response showing in a phase 1/2 study. Just a few months after Boehringer Ingelheim broke into the oncology space with the first drug that can target a rare tumor type in patients with non-small cell lung cancer (NSCLC), the FDA has given its stamp of approval to a competitor in Bayer’s Hyrnuo (sevabertinib).Hyrnuo, a tyrosine kinase inhibitor (TKI), is specifically indicated for patients who have previously received treatment for nonsquamous NSCLC and whose tumors are confirmed to have relatively rare HER2 activating mutations in the tyrosine kinase domain (TKD).The twice-daily oral med was cleared through the FDA’s accelerated approval pathway, meaning it still needs to prove its worth in a confirmatory study. Nonetheless, the FDA saw preliminary evidence of clinical benefit in Bayer’s phase 1/2 Soho-01 trial.Among 70 patients in the open-label study who had received prior systemic therapy but not therapy that specifically targets HER2 mutations, the objective response rate was 71%, according to the FDA. In that group, responses lasted a median 9.2 months, and more than half (54%) of patients experienced a duration of response lasting at least six months.As for the 52 patients in the study who had received prior HER2-targeting antibody-drug conjugates, the objective response rate was 38%. The median duration of response was seven months in that cohort, and 60% of patients maintained a response for at least six months, according to the agency.Bayer estimates that up to 84,000 people are diagnosed with NSCLC that harbors a HER2 mutation each year, the company’s head of R&D, Christian Rommel, Ph.D., said in media statement. Hyrnuo’s accelerated approval "reflects the significant potential of this therapy to advance the treatment paradigm for patients living with HER2-mutated advanced NSCLC in the U.S.," Bayer's U.S. brand lead of precision oncology Chandrasekhar Goda added in a statement.The treatment space in question is currently populated by Boehringer Ingelheim and its TKI Hernexeos, which beat Bayer and Hyrnuo to the chase with a similar FDA nod in August. Although both drugs target the same mutated tumors, Bayer’s med is specifically designated for locally advanced or metastatic nonsquamous NSCLC, while Boehringer’s label holds a small distinction for unresectable or metastatic cancer. In Boehringer’s Lung-1 phase 1b trial, Hernexeos was associated with an objective response rate of 75% among 71 patients who had received prior platinum-based chemotherapy but not a HER2-targeted TKI or ADC, with 58% of patients having a response that lasted for at least six months.With Bayer hot on Boehringer’s tail, both companies are chasing an expanded patient pool in the first-line treatment setting. Each company presented positive data for their respective offerings last month at the European Society of Medical Oncology congress, revealing largely similar outcomes, with Boehringer reporting a 77% objective response rate from its study of treatment-naïve patients and Bayer reading out a result of 71% in the same population.Boehringer, however, has already picked up an FDA breakthrough therapy designation for Hernexeos in the first-line setting. 

The FDA on Wednesday granted accelerated approval to Bayer’s targeted lung cancer drug for certain HER2 mutations, setting up competition with a Boehringer Ingelheim drug that was recently approved for a similar patient group. The treatment, known as sevabertinib, got a thumbs-up for adults with HER2-mutated non-small cell lung cancer who have previously received treatment. The twice-daily oral drug will be marketed as Hyrnuo. Bayer did not immediately respond to a request for comment on list price. Hyrnuo is a HER2 tyrosine kinase inhibitor. The approval was granted based on results from a study called SOHO-01 that included lung cancer patients with HER2 tyrosine kinase domain activating mutations. Among 70 patients who had not tried previous HER2-targeted therapy, 71% saw their tumors shrink by at least 30%. Meanwhile, among 52 patients who previously received a HER2-targeted therapy such as AstraZeneca and Daiichi Sankyo’s Enhertu, the response rate was 38%. Boehringer in August won accelerated approval of Hernexeos, another HER2 tyrosine kinase inhibitor in this previously treated lung cancer population. Both companies in October reported data at ESMO putting them neck-and-neck in first-line HER2-mutated lung cancer, as they seek to expand the use cases for their treatments.