2024 WCLC | Latest Progress of Garsorasib (D-1553) in Treating KRAS G12C-Mutant Lung Cancer: Phase 2 Study Updates

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Tue, 10 Sep 2024 06:54:29 +0000
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2024 World Lung Cancer Conference (WCLC) | Latest Progress of Garsorasib (D-1553) in Treating KRAS G12C-Mutant Non-Small Cell Lung Cancer: Phase 2 Study Updates

The 2024 World Lung Cancer Conference (WCLC) was held from September 7 to 10 in San Diego, USA. During the event, Professor Li Ziming from Shanghai Chest Hospital presented the latest results from the Phase 2 study of Garsorasib (D-1553) in treating KRAS G12C-mutant non-small cell lung cancer (NSCLC) through an oral presentation. The study demonstrated strong clinical efficacy for Garsorasib, with key outcomes further supporting its role as a promising treatment option for this patient population.

Key Findings:

Objective Response Rate (ORR): 52%

Disease Control Rate (DCR): 88.6%

Median Duration of Response (DOR): 12.5 months

Median Progression-Free Survival (PFS): 9.1 months

Median Overall Survival (OS): 14.1 months

These results underline Garsorasib’s effectiveness in treating KRAS G12C-mutant NSCLC, further cementing its clinical value in this patient group.

Study Overview:

Garsorasib (D-1553) is a KRAS G12C inhibitor developed by InventisBio. The Phase 2 study (NCT05383898) was an open-label, multicenter, single-arm trial designed to evaluate Garsorasib’s safety and efficacy in KRAS G12C-mutant, locally advanced or metastatic NSCLC patients. The study was initially presented at the 2024 American Association for Cancer Research (AACR) Annual Meeting and published in The Lancet Respiratory Medicine.

Compared to the previously published data (as of November 17, 2023), the updated data (as of May 17, 2024) shows a median follow-up time of 12.3 months.

Patient Population and Treatment Regimen:

A total of 123 patients received 600 mg BID of Garsorasib for a 21-day treatment cycle. Key inclusion criteria included KRAS G12C-mutant, locally advanced or metastatic NSCLC, with prior progression after anti-PD-(L)1 treatment and platinum-based chemotherapy. The primary endpoint was Objective Response Rate (ORR) assessed by an independent radiology committee (IRC) using RECIST v1.1. Secondary endpoints included DOR, DCR, Time to Response (TTR), PFS, OS, and safety.

Efficacy:

Complete Response: 1 patient

Partial Response: 63 patients

Stable Disease: 45 patients

The ORR confirmed by IRC was 52.0% (64/123, 95% CI: 42.8-61.1), and the DCR was 88.6% (109/123, 95% CI: 81.6-93.6). The median TTR was 1.4 months (IQR: 1.4-1.9), and the median DOR was 12.5 months (95% CI: 8.3-NE). The median PFS increased to 9.1 months (95% CI: 5.6-10.3), and the median OS was 14.1 months (95% CI: 11.5-17.3).

Safety:

95.9% of patients reported treatment-related adverse events (TRAEs), with 51.2% of patients experiencing grade 3 or higher events.

30.1% of patients required dose reduction due to TRAEs.

41.5% of patients had their treatment temporarily interrupted due to TRAEs, but no patients discontinued treatment permanently due to TRAEs.

No new safety signals were identified, and most adverse events were manageable.

Conclusion:

The updated data from this Phase 2 study highlights that Garsorasib continues to demonstrate high tumor response rates and extended duration of response in patients with KRAS G12C-mutant NSCLC. With longer follow-up, Garsorasib also shows favorable tolerability and controllability, making it a potential new treatment option for this patient population.

References:

[1] Original abstract link: WCLC 2024 Abstract
[2] AACR 2024 Annual Meeting: DOI
[3] The Lancet Respiratory Medicine: DOI