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Preliminary Results With Novel EGFR Inhibitor for EGFR-Mutated Lung Cancer

By: Vanessa A. Carter, BS
Posted: Wednesday, July 21, 2021

During the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, James Chih-Hsin Yang, PhD, MD, of National Taiwan University Hospital and National Taiwan University Cancer Center, Taipei, and colleagues presented preliminary efficacy and safety results from their phase I study of DZD9008 (Abstract 9008). Their results with this novel EGFR exon 20 insertion inhibitor in the treatment of non–small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations demonstrated antitumor activity and a “favorable” safety profile.

The researchers enrolled a total of 97 patients with NSCLC who had either EGFR or HER2 mutations. Participants were administered DZD9008 at an increasing dose range of 50 mg to 400 mg, once daily.

The median number of prior therapies was two, with a majority of patients having had previous chemotherapy (92.9%), and nearly half (44.6%) having received a tyrosine kinase inhibitor; 42.9% of individuals had brain metastasis. EGFR exon 20 insertions were identified in 59 participants. DZD9008 was reported to be well tolerated up to 400 mg, although dose-limiting toxicities such as cardiac arrhythmia and diarrhea occurred; grade 3 diarrhea and grade 3 skin rash were among the most common treatment-emergent adverse events, affecting 5.2% and 1% of participants, respectively.

When dose levels reached 100 mg and higher, partial response was observed. At the 300-mg dose level, the disease control rate was 90.3%, and the objective response rate was 48.4%. Notably, two patients with previous JNJ-61186372 treatment (a bispecific antibody targeting EGFR-MET) demonstrated response. At data cutoff, the median duration of treatment was 100 days, and antitumor activity was detected across different subtypes of EGFR exon 20 insertion mutations. With the longest duration of response being more than 6 months, 18 of the 22 patients who responded are still responding to treatment, according to the investigators.

Disclosure: For full disclosures of the study authors, visit coi.asco.org.

 



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