An analysis of GF-105's R&D progress and its clinical results presented at the 2023 AACR Annual Meeting

On 14 Apr 2023, the data from phase I study of IBI351 (GFH925) monotherapy in patients with advanced solid tumors was updated at the AACR Congress.

GF-105's R&D Progress

GF-105 is a small molecule drug developed by GenFleet Therapeutics (Shanghai) Co., Ltd. It falls under the category of biomedicine and is primarily targeted towards KRAS G12C, a specific mutation found in various types of cancers. The drug is being developed for the treatment of neoplasms, respiratory diseases, and digestive system disorders.

According to the Patsnap Synapse, GF-105 has reached the highest phase of clinical development globally, which is Phase 3. And the clinical trial areas for GF-105 are primarily in the China and Spain. The key indication is Non-Small Cell Lung Cancer. 

Detailed Clinical Result of GF-105

This phase I study (NCT05005234) was aimed to assess the efficacy and safety of IBI351 (GFH925) in patients (pts) with advanced solid tumors harboring KRAS p.G12C mutation. 

In this study, pts with locally advanced, recurrent or metastatic solid tumors with KRASG12C mutation for whom standard therapy had failed were enrolled. Phase I dose escalation had an accelerated titration design for dose level 250mg once daily (QD) and a Bayesian optimal interval (BOIN) design with 450-900mg QD and 450-750mg twice daily (BID). The primary endpoints were safety and tolerability. The secondary endpoints were pharmacokinetics (PK), anti-tumor activity of IBI351 (GFH925) monotherapy per RECIST v1.1, and overall survival. 

The result showed that as of November 30th, 2022, 74 pts (1 at 250mg QD, 3 at 450mg QD, 9 at 700mg QD, 5 at 900mg QD, 21 at 450mg BID, 31 at 600mg BID and 4 at 750mg BID; 62 men, 12 women; median age: 64 yrs, range: 42-76 yrs) were enrolled, among whom 67 pts had non-small cell lung cancer (NSCLC). Among 67 NSCLC pts, 44.8% pts received ≥2 prior lines of treatment (tx), 38.8% pts had brain metastases; adenocarcinoma was the most common histology (n=66, 98.5%). All 74 pts were included for safety analysis. No dose-limiting toxicity (DLT) were observed in any dose cohorts. The overall safety profile was consistent with the latest previous report, with no new safety signals identified. As of December 15th, 2022, among 67 response-evaluable NSCLC pts across all dose levels, the ORR (by investigator assessment) was 58.2% (95% CI, 45.5-70.2), and the confirmed ORR was 44.8% (95% CI, 32.6-57.4); the disease control rate (DCR) was 92.5% (95% CI, 83.4-97.5). At the 600mg BID dose level (RP2D), the ORR was 63.3% (95% CI, 43.9-80.1), and the confirmed ORR was 50.0% (95% CI, 31.3-68.7), the DCR was 96.7% (95% CI, 82.8-99.9). With a median progression-free survival (PFS) follow-up of 5.5 months (95% CI, 5.3-6.8) for NSCLC pts at the 600mg BID dose level, 21 (70%) pts were continuing treatments, and the median duration of response (DoR) and PFS were not reached. Thirteen out of 15 confirmed responders were still in response.

It can be concluded that IBI351 (GFH925) was well-tolerated across all doses explored in patients with advanced solid tumors harboring KRAS p.G12C mutation. The data also demonstrated promising efficacy and durable response of IBI351 (GFH925) in previously treated advanced NSCLC.

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