Less than six months after debuting as the first drug that can target a rare tumor type in patients with non-small cell lung cancer (NSCLC), Boehringer Ingelheim’s Hernexeos has quickly widened its reach into the first-line setting with a speedy FDA approval that comes from the FDA Commissioner’s National Priority Voucher (CNPV) pilot program.
The nod allows Hernexeos (zongertinib) to be used as an initial treatment option for NSCLC with HER2-activating mutations in the tyrosine kinase domain (TKD), building on its initial approval in August for those who had received prior systemic therapy.
Hernexeos had just barely gotten its feet off the ground when the FDA awarded the innovation with a CNPV in October, underscoring its potential to “meet critical patient needs for this rare and aggressive cancer,” Boehringer said at the time.
The CNPV program, which launched last June, aims to cut down drug approval times from 10 to 12 months down to one or two months for medicines that align with U.S. national priorities.
Hernexeos’ first-line nod marks the FDA’s second approval issued under its CNPV program, with the first going to USAntibiotics in December.
“As a part of the national priority voucher program, the FDA is on the hunt for game-changing therapies that can qualify for a priority review. In this case, a final decision was rendered 44 days after the filing date,” FDA Commissioner Marty Makary, M.D., said in a Thursday press release announcing the approval. “Patients and sponsors deserve an efficient FDA process that cuts out idle time and delivers powerful treatments safely and quickly for the American people.”
Makary pre-notified the approval at a Thursday morning appearance on CNBC’s Squawk Box, teasing a decision on a “powerful new drug for a type of cancer.”
Although Boehringer’s expanded approval application was filed on Jan. 13, according to the FDA, the first-line indication for Hernexeos was already “under the accelerated approval pathway” before the FDA nominated it for a CNPV in October, Boehringer’s head of U.S. oncology, Vicky Brown, told Fierce Pharma in a December interview.
The FDA attributed its decision to results from a cohort of treatment-naïve patients in Boehringer’s Beamion Lung-1 study, in which Hernexeos delivered an objective response rate of 76%. 64% of patients saw a duration of response lasting six months or more, the company said in a press release.
NSCLC is the most common type of lung cancer, with up to 4% of lung cancers linked to HER2 mutations, according to Boehringer. The mutations can spread tumors faster and leave many patients diagnosed “very late,” when the cancer is already in advanced stages, Brown explained.
This may be due, in part, to the demographics of the patient population. Aside from the subset of patients who are classified as non-smokers, those impacted by the mutated lung cancer skew more toward younger women, and as Brown points out, “no one thinks lung cancer” when those younger patients present with symptoms.
Hernexeos' use in this setting stands to “reset the benchmark of what's expected,” Brown explained.
“We bring that personalized care back to reality for a group of patients in a community that desperately needs it, given the advanced stage their cancers have been diagnosed in,” she said.
A leg up on Bayer competition
Boehringer’s CNPV gave it more breathing room from its new rival in Bayer’s twice-daily Hyrnuo. After Boehringer cracked open the new treatment market in August, Bayer stepped in with a nearly matching later-line indication for Hynuo in November. From there, the race was on for the coveted first-line nod. Bayer has reported a 71% objective response rate in its own study across treatment-naïve patients and received a breakthrough therapy designation from the FDA for Hyrnuo’s front-line ambitions last month.
Despite the competition, “we all have the same goal” of delivering an efficient treatment option to patients, Brown said, although she points out that Hernexeos is the only once-daily oral therapy cleared for the patient population.
As part of the accelerated approval, Boehringer will have to verify Hernexeos’ first-line benefits in a confirmatory trial, for which it is already enrolling patients.