KEY TAKEAWAYS
- The phase 3 EXCLAIM-2 study aimed to compare mobocertinib vs. chemo in EGFR Exon 20+ NSCLC.
- Primary endpoint: PFS.
- At initial assessment, mobocertinib showed comparable efficacy but not superiority to first-line platinum-based chemotherapy. The safety profile remained consistent.
In this study, the researchers reported the latest outcomes from the EXCLAIM-2 trial that compares first-line mobocertinib treatment and platinum-based chemotherapy for those with EGFR ex20ins+ advanced/metastatic NSCLC.
The newly diagnosed patients with EGFR ex20ins+ locally advanced/metastatic NSCLC were randomly assigned (1:1) to receive either daily oral mobocertinib 160 mg or standard chemotherapy (pemetrexed plus cisplatin/carboplatin).
The investigators evaluated responses based on RECIST v1.1 criteria. It aimed to determine progression-free survival (PFS) through a planned interim analysis conducted after 184 events, assessed by a blinded independent review committee (BIRC).
There were 354 participants (179 on mobocertinib; 175 on chemotherapy), and baseline characteristics were evenly distributed. As of April 4, 2023, an interim analysis showed a similar median PFS (approximately 9.6 months) between mobocertinib and chemotherapy arms, with no significant difference (BIRC PFS HR=1.038, P=0.803).
The study met predefined futility criteria, indicating comparable efficacy. Objective response rates were 32% (mobocertinib) and 30% (chemotherapy), with longer response duration on mobocertinib (12 months vs. 8 months).
Grade ≥3 adverse events occurred in 62% (mobocertinib) and 53% (chemotherapy) of participants, with similar discontinuation rates due to adverse events or death between the arms. Mobocertinib showed a delay in lung cancer symptom deterioration.
At interim analysis, mobocertinib’s effectiveness was comparable but not superior to first-line platinum-based chemotherapy. Safety profiles aligned with prior findings, showing no new safety issues.
Source: https://cslide.ctimeetingtech.com/asia2023/attendee/confcal/show/session/40
Clinical Trial: https://clinicaltrials.gov/study/NCT04129502
Jänne, P. A., Wang, B.-C., Cho, B. C. (2023). “EXCLAIM-2: Phase III trial of first-line (1L) mobocertinib versus platinum-based chemotherapy in patients (pts) with epidermal growth factor receptor (EGFR) exon 20 insertion (ex20ins)+ locally advanced/metastatic NSCLC.” Presented at the ESMO Asia Congress 2023, December 01 – December 03, 2023, Singapore. Presentation Number: 507O.
