ESMO: AstraZeneca spinout Dizal planning phase 3 NSCLC study in US before year-end

Dizal Pharmaceuticals, an AstraZeneca spinout that launched in 2017, is slated to launch a phase 3 trial of its targeted non-small cell lung cancer (NSCLC) candidate in the U.S. before the end of the year. 

Fierce Biotech learned of the fast-moving clinical plans in an interview Monday with Dizal CEO Xiaolin Zhang, Ph.D., at the European Society for Medical Oncology (ESMO) congress. The Chinese company is currently in advanced talks with the FDA regarding the proposed trial, Zhang said.

The news comes the same day the biotech presented data on the phase 2 trial of the treatment, called sunvozertinib. The EGFR inhibitor is targeted at a subset of NSCLC patients with exon 20 insertion mutations who have already been treated with platinum chemotherapy. According to the FDA, 2% to 3% of NSCLC patients will have exon 20 insertion mutations, which spur even quicker cancer cell growth. 

An early tease of the data released last week found that the confirmed objective response rate (ORR) among 97 patients was nearly 60%. In patients with brain metastasis, the confirmed ORR was 48.5%. A median duration of response was not mature enough at the time of data publication.

In terms of safety, nearly 20% of a population of 277 patients required a reduced dose due to side effects. However, only around 6% of patients discontinued treatment due to adverse events.

The response rates have infused the biotech with confidence as it goes up against top industry players that received FDA approval in 2021 for the same group of patients. Takeda’s Exkivity and Johnson & Johnson’s Rybrevant nabbed approval with overall response rates of 28% and 40%, respectively. When asked whether Dizal had plans to run any head-to-head trials against these big names, Zhang said, “We don’t see real competitors.” 

“I think we're setting the bar in this area,” the CEO added. In terms of the durability data, Zhang is bullish that the strong response data will translate. 

Dizal spun out of AstraZeneca R&D Asia in 2017 to be a standalone company based across three locations in China. But its focus is not solely on that market, hence the U.S. plans. Zhang said the biotech has drawn interest in sunvozertinib from almost all the multinational “big boys.” The company is open to a deal but also has the money to continue development plans on its own, he explained.