Officially Approved. Anfangning (KRAS G12C Inhibitor Garsorasib) Receives Market Authorization from the National Medical Products Administration (NMPA) of China

November 8, 2024 – InventisBio’s KRAS G12C Inhibitor Anfangning (Garsorasib, D-1553) Receives Market Authorization from the National Medical Products Administration (NMPA) of China

Anfangning (Garsorasib), a KRAS G12C inhibitor developed by InventisBio, has been officially approved by the National Medical Products Administration (NMPA) of China for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harboring the KRAS G12C mutation, who have previously received at least one systemic therapy. This approval injects new vitality into the field of precise targeted therapy for NSCLC and provides a new option for lung cancer patients in China to combat the disease.

Lung cancer is the leading cause of cancer-related mortality worldwide, and the disease burden is particularly significant in China. According to data from the National Cancer Center in 2022, there are approximately 1.06 million new lung cancer cases in China each year, which translates to 75.1 cases per 100,000 people. The incidence is rising, and the mortality rate is also high, with 51.9 per 100,000 people dying from lung cancer. Research shows that the five-year survival rate for lung cancer patients in China was only 19.7% between 2012 and 2015. NSCLC accounts for approximately 85% of all lung cancer cases, and KRAS mutations, second only to EGFR mutations, are the most common driver gene mutations in NSCLC. Among KRAS mutations, G12C is the most prevalent subtype in NSCLC patients. In China, approximately 2.9–4.3% of NSCLC patients carry the KRAS G12C mutation, compared to around 15% of NSCLC patients in other countries. These patients tend to experience rapid disease progression and poor prognosis. Current treatment guidelines, including those from NCCN and CSCO, recommend platinum-based doublet chemotherapy combined with immune checkpoint inhibitors, but these patients show limited sensitivity to chemotherapy and immunotherapy. Some studies suggest that for KRAS G12C-mutant NSCLC, immune combination chemotherapy did not significantly improve overall survival (OS) compared to placebo-based first-line treatment (immuno-chemotherapy group mOS 18 months vs placebo group mOS 25 months, HR=1.14, 95% CI 0.45–2.92) [1]. Overall, this patient population has limited benefit from existing non-targeted treatment options, and chemotherapy-related toxicities significantly impact their quality of life, highlighting the urgent need for more effective and convenient treatment options.

Anfangning (Garsorasib) is a targeted drug developed by InventisBio specifically for KRAS G12C-mutant tumors. In August 2023, InventisBio entered into an exclusive licensing agreement with CTTQ Pharma. for the commercialization of Anfangning in mainland China. From the initiation of clinical trials in 2021 to receiving priority review qualification and successfully obtaining market approval this year, InventisBio completed the entire clinical translation process of Garsorasib in just three years. This achievement underscores InventisBio’s core drive of independent R&D, efficiently advancing clinical product development and registration, and continuously demonstrating its market competitiveness.

This approval is primarily based on a pivotal Phase II multicenter, single-arm, open-label study (NCT05383898) conducted in KRAS G12C-mutant, locally advanced or metastatic NSCLC patients. The study was led by Professor Lu Shun of Shanghai Chest Hospital, in collaboration with multiple hospitals nationwide, and aimed to evaluate the efficacy, safety, and tolerability of Garsorasib as a monotherapy for KRAS G12C-mutant NSCLC.

As of May 17, 2024, 123 patients had been enrolled in this pivotal study, with a median follow-up time of 12.3 months. Garsorasib demonstrated good tolerability. The objective response rate (ORR) was 52.0%, the disease control rate (DCR) was 88.6%, the median duration of response (DOR) was 12.5 months, the median progression-free survival (PFS) was 9.1 months, and the median overall survival (OS) was 14.1 months. The latest results of this study were presented as an oral presentation at the 2024 World Lung Cancer Conference (WCLC) [2].

Dr. Yaolin Wang, CEO of InventisBio, commented:

“KRAS mutations are one of the common genetic mutations in NSCLC, once considered an ‘undruggable’ target. The successful launch of Anfangning is undoubtedly a boon for patients with KRAS G12C-mutant NSCLC, and it brings new hope for the precise targeted treatment of lung cancer. As InventisBio’s second in-house developed product to successfully complete clinical translation, Anfangning will help extend patient life expectancy and improve quality of life, and we believe it will benefit more patients in the future. InventisBio will continue to focus on innovation, developing new drugs with clinical value, and contributing to the ‘chronic disease’ era in oncology.”

References:

[1] KRAS mutational status and efficacy in KEYNOTE-189: Pembrolizumab (pembro) plus chemotherapy (chemo) vs placebo plus chemo as first-line therapy for metastatic non-squamous NSCLC. Gadgeel, S. et al. Annals of Oncology, Volume 30, xi64 – xi65.

[2] OA14.03 Garsorasib in KRAS G12C-Mutated Non-Small-Cell Lung Cancer: Updated Results from a Phase 2 Study. Li, Z. et al. Journal of Thoracic Oncology, Volume 19, Issue 10, S40 – S41.