AstraZeneca’s Zegfrovy demonstrated a 46% overall response rate in a trial supporting its accelerated FDA approval, as the company seeks clearance to use the lung cancer drug as a first-line treatment.

  • AstraZeneca has submitted applications in the U.S. and China seeking first-line use, with both regulators granting Breakthrough Therapy Designation for this setting.
  • Among the 39 patients who responded, the median duration of response was 11.1 months; 72% had responses lasting at least six months.
  • Zegfrovy is listed in the NCCN guidelines as a Category 2A recommended subsequent therapy for eligible patients with advanced or metastatic NSCLC carrying EGFR exon 20 insertion mutations.

AstraZeneca (AZN) shares drew investor attention on Thursday after the biopharmaceutical company announced the U.S. launch of its lung cancer drug Zegfrovy (Sunvozertinib).

The drug is indicated for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) carrying EGFR exon 20 insertion mutations, detected using an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. 

AstraZeneca said Zegfrovy is the only approved oral, single-agent targeted therapy following platinum-based chemotherapy.

AZN shares traded 2% higher at the time of writing.

Trial Shows 46% Overall Response Rate

The U.S. Food and Drug Administration granted Zegfrovy accelerated approval based on results from the WU-KONG1B trial. Among 85 patients evaluated, the drug achieved a confirmed overall response rate of 46%.

Of the 39 patients who responded to treatment, the median duration of response was 11.1 months. The company said 72% of responding patients had a response lasting at least six months. Continued approval for this indication may depend on confirmation of clinical benefit in additional trials.

“By making ZEGFROVY available in the US, we are bringing an oral, mutation-specific treatment option to a distinct patient population with substantial unmet need,” Mohit Manrao, senior vice president of U.S. Oncology at AstraZeneca, said.

AstraZeneca Seeks First-Line Approval

Additionally, AstraZeneca has submitted applications to the U.S. FDA and China’s Center for Drug Evaluation seeking approval for Zegfrovyl. Both regulators have granted Breakthrough Therapy Designation for this use, but the applications are still pending.

Zegfrovy is also included in the National Comprehensive Cancer Network’s NSCLC guidelines as a Category 2A recommended subsequent therapy option for patients with advanced or metastatic disease carrying EGFR exon 20 insertion mutations.

The drug is taken orally once daily with food. AstraZeneca warns that it can cause severe or life-threatening adverse reactions, including interstitial lung disease or pneumonitis, gastrointestinal reactions, severe rash and ocular toxicity.

How Retail Views AZN 

On Stocktwits, retail sentiment toward AZN remained in the ‘bullish’ territory over the past 24 hours amid ‘neutral’ message volumes.

AZN shares have dropped over 8% year-to-date.

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