Sunvozertinib Meets Primary Endpoint in First Pivotal Study in Platinum-Pretreated NSCLC With EGFR Mutations


Sunvozertinib is an oral, potent EGFR exon20ins inhibitor with wild-type EGFR selectivity.

New topline results from the first pivotal study of sunvozertinib (DZD9008, Dizal) have found that the treatment met the primary endpoint of confirmed objective response rate (cORR) in patients with platinum-pretreated non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion (exon20ins) mutations.1

According to data announced at the European Society for Medical Oncology 2022 Congress, the cORR as assessed by blinded independent central review was 59.8% in advanced NSCLC with EGFR exon20ins mutations after at least 1 line of platinum-based chemotherapies. Furthermore, the response rate for patients with baseline brain metastasis was 48.4%. Clinical activities were observed across a broad range of EGFR exon20ins mutation subtypes and regardless of mutation positions.1

Despite the fact that lung cancer is the second most common form of the disease and a leading cause of cancer-related deaths globally, patients with NSCLC and EGFR exon20ins mutations lack effective treatment options. In particular, patients who develop brain metastases have historically had worse outcomes, according to the press release.1

Sunvozertinib is an oral, potent EGFR exon20ins inhibitor with wild-type EGFR selectivity and was previously granted Breakthrough Therapy Designation by the FDA. It was designed with the goal of addressing the limitations of existing NSCLC therapies and is an irreversible inhibitor targeting EGFR exon20ins mutations, as well as EGFR sensitizing T790M and uncommon mutations.1

The new findings come from the WU-KONG6 study, which is a multicenter, single-arm, phase 2 pivotal trial conducted in China. As of July 31, 2022, the efficacy set included 97 platinum-pretreated NSCLC patients with EGFR exon20ins mutations.1

Of the 97 patients in the efficacy set, the median age was 58, 59.8% were female, and 100% were Asian. Nearly half (49.5%) had received 1 prior line of systemic anti-cancer treatment and 50.5% had received more than 1 line.1

All 97 patients had received platinum-based chemotherapy, 34% had received programmed death cell-1 (PD-1) or programmed death cell-ligand 1 (PD-L1) therapy, and 32% had received treatment with an EGFR tyrosine kinase inhibitor. A total of 30 subtypes of EGFR exon20ins mutations were enrolled.2

Sunvozertinib also demonstrated a favorable safety profile. Among all 277 patients in the safety set, the most common treatment-related adverse events (AEs) were diarrhea and rash, the majority of which were Grade 1 or 2 and clinically manageable. Other common treatment-emergent AEs included anemia, stomatitis, paronychia, decreased appetite, nausea, and vomiting.2

“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,” said Xiaolin Zhang, MD, CEO of Dizal, in the press release. “It is great news to our patients that sunvozertinib is showing such strong antitumor activities with a benign safety profile. [These] data further strengthens our confidence in sunvozertinib and reinforces its best-in-class position.”1


1. Dizal Announces Sunvozertinib Meets Primary Endpoint in its First Pivotal Study in Platinum-Pretreated NSCLC Patients with EGFR Exon20ins Mutations at 2022 ESMO. News release. Dizal; September 5, 2022. Accessed September 9, 2022. Email.

2. Wang M, Fan Y, Sun M, Wang Y, et al. Sunvozertinib for NSCLC Patients with EGFR Exon20 Insertion Mutations: Preliminary Analysis of the First Pivotal Study Results. Poster; ESMO Congress 2022. Accessed September 9, 2022.

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