#ESMO22: Dizal touts win in niche NSCLC population cornered by Takeda, J&J
AstraZeneca spinout Dizal said its cancer drug cleared the primary goal in a Phase II trial of patients with EGFR exon 20 insertion mutations, for which Takeda and J&J have approved meds, and others like Cullinan Oncology and Blueprint Medicines are attempting to treat.
Sending out the data in the early hours of this year’s European Society for Medical Oncology meeting in Paris, Dizal said 59.8% of patients evaluable as of the end of July had a confirmed objective response. The study, conducted in China, tested the breakthrough-designated sunvozertinib in platinum-pretreated non-small cell lung cancer patients who have EGFR exon 20 insertion mutations.
That population, about 2% to 3% of patients with NSCLC, has two approved drugs: Takeda’s Exkivity and Johnson & Johnson’s Rybrevant. The FDA greenlit both in 2021.
Shanghai-based Dizal said 58 of 97 patients (59.8%) in the 300 mg cohort had a confirmed objective response, as determined by the blinded independent central review team. Out of 31 patients who had baseline brain metastasis, 15 of them (48.4%) had a confirmed objective response.
The WU-KONG6 trial, which Dizal is billing as a pivotal study, had 277 patients evaluable for safety, with diarrhea and rash being the most common treatment-related adverse events, the biotech said. The adverse effects were “mild in nature and reversible,” the company said.
Dizal offered no other data from the study in its short press release Tuesday.
The biotech, launched as a joint venture between AstraZeneca and a China-owned private equity shop in 2017, had previously attempted to test the drug in patients with non-Hodgkin’s B cell lymphoma, but that trial was suspended due to “clinical development strategy adjustment, non-safety reason,” according to an update to the US federal clinical trials database.
With breakthrough tags both in the US and China, Dizal said the drug is in “global pivotal studies” for first-line and beyond the treatment of the niche NSCLC population, with trials in China, the US, EU, Australia, South Korea and elsewhere.
“The importance of advancing research on NSCLC with EGFR exon20ins mutation — a complicated and devastating disease — cannot be overstated, as available treatment options provide limited benefit, especially to those who develop brain metastasis,” CEO Xiaolin Zhang said in a statement.
Dizal’s data drop follows that of Cullinan at this year’s ASCO, where the biotech showed that its oral tyrosine kinase inhibitor led to median progression-free survival of about 12 months in a Phase I/IIa study. The trial of CLN-081 also showed that 28 of 73 overall patients had a confirmed partial response. Another 42 had stable disease and 3 had progressive disease, Cullinan reported at the US oncology confab in Chicago in June.
Also in the EGFR 20 field is Blueprint Medicines, which entered the clinic with a drug, BLU-451, targeting the mutations in March thanks to its acquisition of Lengo Therapeutics in late 2021.