On September 5, 2022 Dizal reported positive topline results from the first pivotal study of sunvozertinib (DZD9008) in platinum-pretreated NSCLC Patients with EGFR exon20ins mutations at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting (Press release, Dizal Pharma, SEP 5, 2022, View Source [SID1234619001]). The trial met the primary endpoint, cORR, as assessed by Blinded Independent Central Review (BICR).

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Even though lung cancer is the second most common cancer and leading cause of cancer death globally, NSCLC patients with EGFR exon20ins mutation lack effective treatment options, especially those who develop brain metastases (BM) historically have worse outcomes. Sunvozertinib (DZD9008), which was granted Breakthrough Therapy Designation by both the US FDA and China CDE, is a rationally designed, oral, potent EGFR exon20ins inhibitor, with wild-type EGFR selectivity.

The topline result presented at 2022 ESMO (Free ESMO Whitepaper) was based on the latest data from WU-KONG6 study, the multicenter, single-arm, Phase II pivotal study conducted in China. As of 31 July 2022, the efficacy set included 97 platinum-pretreated NSCLC patients with EGFR exon20ins mutations. Key findings from efficacy set are as follows:

Parameter

Results in 300 mg cohort (N=97)

Confirmed ORR per BICR

59.8% (58/97)

Confirmed ORR in patients with baseline brain
metastasis per BICR

48.4% (15/31)

*Patients are still on treatment and responding.

Sunvozertinib also demonstrated a favorable safety profile. Of all 277 patients in the safety set, the most common treatment-related adverse events (TEAE) were diarrhea and rash, the majority of which were Grade 1/2 and clinically manageable.

"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 develop brain metastasis," said Dr. Xiaolin Zhang, CEO of Dizal, "It is great news to our patients that sunvozertinib is showing such strong antitumor activities with a benign safety profile. This data further strengthens our confidence in sunvozertinib and reinforces its best-in-class position"

About sunvozertinib (DZD9008)

Sunvozertinib was designed with the goal to address the limitations of existing NSCLC therapies. It is an irreversible inhibitor targeting EGFR exon 20 insertion mutations as well as EGFR sensitizing T790M and uncommon mutations while maintaining selectivity against wild-type EGFR. The first pivotal study WU-KONG6 of sunvozertinib has achieved its primary endpoint, demonstrating superior antitumor efficacy in pre-treated NSCLC patients with EGFR exon20 insertion mutations. The confirmed ORR (cORR) at 300 mg was 59.8% by BICR. Patients with baseline brain metastasis showed significant response as well, with a confirmed ORR of 48.4%. (Data cut-off date: July 31, 2022). It is well tolerated with a manageable AE profile. Global pivotal studies are ongoing for ≥ 2nd line and 1st line treatment of NSCLC with EGFR exon20 insertion mutation in countries including China, U.S., EU, Australia, South Korea and other countries and regions.

About EGFR Exon20ins

Lung cancer is the leading cause of cancer death in the world. It is classified broadly as non-small cell lung cancer (NSCLC), accounting for 85% lung cancer cases, and small cell lung cancer (SCLC). EGFR mutation is common in NSCLC. About 4–12% of all EGFR mutations are insertions at exon 20 (EGFR exon20ins). Patients with EGFR exon20ins generally don’t respond to the first-, second- and third-generation EGFR tyrosine kinase inhibitors (TKIs).