Anfangning (garsorasib) / InventisBio, Sino Biopharm - LARVOL DELTA

Garsorasib, a KRAS G12C inhibitor, with or without cetuximab, an EGFR antibody, in colorectal cancer cohorts of a phase II trial in advanced solid tumors with KRAS G12C mutation. (PubMed, Signal Transduct Target Ther) - P1/2 | "Grade ≥3 treatment-related adverse events occurred in 5 (19.2%) and 6 (14.3%) patients in monotherapy and combination cohort, respectively. Garsorasib with or without cetuximab showed a promising efficacy and manageable safety profiles in heavily pretreated patients with KRAS G12C-mutated CRC, providing a potential new treatment approach for such population."

Journal • P2 data • Colorectal Cancer • Oncology • Solid Tumor • KRAS

KRAS-Targeted Therapies in NSCLC: Resistance, Combination Strategies, and Emerging Clinical Paradigms. (PubMed, Med Oncol) - "Sotorasib and adagrasib achieve ORRs of 37-43% and median PFS ~ 6-7 months in previously treated KRAS G12C NSCLC, with improved tolerability over docetaxel. Next-generation inhibitors (olomorasib, divarasib, glecirasib, D-1553, IBI351) demonstrate ORRs 45-55% and, in some studies, PFS exceeding first-generation agents, while emerging KRAS G12D inhibitors show early proof-of-concept activity...KRAS-mutant NSCLC is transitioning from historically untargetable disease to a therapeutically actionable subset. Future progress hinges on resistance-directed combinations, biomarker-guided personalization, expansion to non-G12C mutants, and evaluation in earlier disease settings."

IO biomarker • Journal • Review • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS

Safety and efficacy of D-1553 in combination with cetuximab in KRAS G12C mutated colorectal cancer (CRC): A phase II study (ESMO 2023) - P1/2 | "Conclusions Combination of D-1553 and cetuximab showed an acceptable safety profile and achieved a higher response rate than D-1553 monotherapy and a promising PFS in heavily pretreated pts with KRAS G12C mutated CRC. More data will be presented at the meeting."

Clinical • Combination therapy • P2 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • KRAS

Ifebemtinib plus garsorasib as first-line treatment for KRASG12C-mutated non-small-cell lung cancer in China: a multicentre, single-arm expansion cohort from a phase 1b/2 trial. (PubMed, Lancet Respir Med) - P1/2, P3 | "The dual-oral chemotherapy-free regimen of ifebemtinib plus garsorasib had encouraging efficacy with a manageable safety profile as first-line treatment for KRASG12C-mutated NSCLC. A randomised phase 3 study has been initiated to further validate these findings against standard-of-care in the first-line setting (NCT07174908)."

Journal • P1/2 data • Cardiovascular • Cerebral Hemorrhage • Hematological Disorders • Hypertension • Infectious Disease • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pneumonia • Renal Disease • Respiratory Diseases • Solid Tumor • KRAS

D-1553 (garsorasib), a Potent and Selective Inhibitor of KRAS in Patients with Non-Small Cell Lung Cancer: Phase I Study Results. (PubMed, J Thorac Oncol) - "D-1553 represents a promising therapeutic option for patients with KRAS G12C-mutated NSCLC with a well-tolerated safety profile and encouraging anti-tumor activity."

Journal • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS

Garsorasib in KRAS G12C-Mutated Non-Small-Cell Lung Cancer: Updated Results from a Phase 2 Study (IASLC-WCLC 2024) - P1/2 | "Conclusions : Garsorasib has shown a high tumor response rate and long duration of response in a pretreated population of patients with KRAS G12C-mutated NSCLC. After prolonged follow up, the updated PFS and OS suggest a long-term clinical benefit, which will be further evaluated in a randomized, double-blind, controlled trial."

P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS

Safety and Efficacy of D-1553 in Patients with KRAS G12C Mutated Non-Small Cell Lung Cancer: A Phase 1 Trial (IASLC-WCLC 2022) - P1/2 | "D-1553 was well tolerated, with promising antitumor activity in heavily pretreated KRAS G12C mutant-NSCLC patients. The study is ongoing, and more results will be presented at the meeting."

Clinical • P1 data • Anemia • Hematological Disorders • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS

InxMed Announces Publication in The Lancet Oncology Featuring Encouraging Antitumor Activity of Ifebemtinib in Combination with Garsorasib in Previously Treated Metastatic Colorectal Cancer (CRC) Harboring KRAS G12C Mutation (Yahoo Finance) - "The CRC cohort of this trial contains two parts: Part 1-single-arm study and Part 2-randomized study...In the single-arm study, 15 patients were enrolled with 14 patients evaluable, and the confirmed ORR was 46.7% (95% CI: 21.3–73.4) in the full population and 50.0% (95% CI: 23.0–77.0) in the evaluable population. In the randomized study, the confirmed ORR was 38.9% (95% CI: 17.3–64.3) in the ifebemtinib plus garsorasib group versus 16.7% (95% CI: 3.6–41.4) in the garsorasib monotherapy group, representing an absolute improvement of 22.2% in the combination group...In the single-arm study, the median OS was 14.3 months (95% CI: 4.7–NE). In the randomized study, the median OS was not estimable (95% CI: 10.2–NE) in ifebemtinib plus garsorasib group versus 7.5 months (95% CI: 5.3–NE) in garsorasib monotherapy group (HR 0.34, 95% CI: 0.11–1.12), suggesting a favorable OS trend in the combination group."

P1/2 data • Colorectal Cancer

A Multicenter, Open-label Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of GH21 Combined With D-1553 in Patients With Advanced or Metastatic Solid Tumors Harboring KRAS G12C Mutation (ChiCTR) - P1/2 | N=126 | Recruiting | Sponsor: Zhejiang Cancer Hospital; Zhejiang Cancer Hospital

New P1/2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS • PD-L1

Study to Evaluate D-1553 in Combination With IN10018 in Subjects With Solid Tumors (clinicaltrials.gov) - P1/2 | N=92 | Active, not recruiting | Sponsor: InventisBio Co., Ltd | Trial completion date: Dec 2025 ➔ Aug 2029 | Trial primary completion date: Jul 2025 ➔ Dec 2027

Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS

Safety and efficacy of ifebemtinib combined with garsorasib in KRAS G12C mutant colorectal cancer from a randomized part of a phase Ib/II study. (ASCO 2026) - P1/2 | "The combination of ifebe and D-1553, a dual-oral regimen, exhibits favorable safety profiles and better efficacy in treating KRAS G12C mutant CRC, with mOS exceeding 16 months. Clinical findings from this randomized study have shown robustness of improvement in overall ORR, PFS, DOR and OS benefit with this combination regimen, indicating that adding ifebe to a RASi can further improve clinical outcome to CRC patients with RAS G12C mutation. Efficacy."

Clinical • P1/2 data • Colorectal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS

Safety and efficacy of ifebemtinib (IN10018) combined with garsorasib (D-1553) in KRASG12C mutant solid tumors from a phase Ib/II study: 2-year follow-up from single-arm of non-small-cell lung cancer (NSCLC). (ASCO 2026) - P1/2 | "Ifebe plus D-1553 exhibited robust, durable antitumor activity and a favorable safety profile in treatment-naïve KRASG12C-mutant NSCLC patients regardless of PD-L1 expression. Notably, TP53-wild-type KRASG12C tumors typically show poor responsiveness and short durability to ICI therapies, likely due to reduced PD-L1 expression and lower tumor mutational burden. The superior outcomes in TP53 wild-type patients suggest this combination may address an unmet need in this distinct population."

Clinical • IO biomarker • P1/2 data • Tumor mutational burden • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS • TMB • TP53

Trends in historical response rates: A meta-analysis of KRAS G12C inhibitors in pretreated metastatic pancreatic cancer—Effects on ORR and disease control. (ASCO 2026) - "The development of covalent KRAS G12C inhibitors—including sotorasib, adagrasib, garsorasib, glecirasib, and divarasib—has opened new therapeutic options for this molecularly defined subset of PDAC patients. KRAS G12C inhibitor monotherapy demonstrates clinically significant and durable efficacy in pretreated adults with advanced/metastatic PDAC harboring the KRAS G12C mutation. The pooled ORR of approximately one-third, together with a DCR near 90%, indicates substantial tumor control in a population with historically poor outcomes. Median PFS of approximately 5 months and OS of nearly 9 months represent clinically relevant improvements over standard salvage therapies, supporting KRAS G12C inhibitors as a viable option after chemotherapy failure."

Metastases • Retrospective data • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • KRAS

A Trial of HRS-7058 in Advanced or Metastatic Non-Small Cell Lung Cancer Patients Who Have Failed Standard Treatment (clinicaltrials.gov) - P3 | N=450 | Not yet recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd.

New P3 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS

Assessing the Potential Clinical Drug-Drug Interactions Between D-1553 (Garsorasib) and CYP450 Enzymes/Transporters via a Cocktail Approach. (PubMed, Clin Ther) - "D-1553 acts as a moderate inhibitor of CYP3A4 and a weak inhibitor of P-gp, while reducing the absorption of specific transporter substrates, likely via intestinal OATP2B1. Co-administration with strong CYP3A4 inhibitors moderately increases D-1553 exposure, whereas acid-reducing agents like omeprazole have no clinically relevant effect. These findings provide a targeted scientific basis for guiding the clinical co-administration of D-1553 with concomitant medications."

Journal • CYP1A2 • SLCO2B1

Open-label, single-arm, multicenter, phase 2 trial of garsorasib in KRAS G12C-mutated non-small-cell lung cancer (AACR 2024) - "Garsorasib has shown a high tumor response rate and long response duration in patients with KRAS G12C mutated NSCLC that have progressed after prior anti-PD-(L)1 therapy and platinum-based chemotherapy. Its safety profile was also shown to be well-tolerated and manageable. Garsorasib could be considered as a promising treatment option for KRAS G12C-mutant NSCLC patients with a high unmet medical need."

Clinical • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS

Galaxy-L-01: A multicenter, prospective study of garsorasib combined with anlotinib as first-line therapy for KRAS G12C-mutated locally advanced or metastatic non-squamous non-small cell lung cancer (ELCC 2026) - P4 | "A total of 82 eligible patients will be randomized 1:1 to either the experimental combination of garsorasib plus anlotinib (dose from single-arm phase) or standard pemetrexed-platinum chemotherapy plus PD-(L)1 inhibitor. Randomized phase primary endpoint is PFS, with secondary endpoints including DOR, DCR, TTR, OS and safety. The study is actively recruiting and has 3 patients enrolled as of 10-Jan-2026."

Clinical • IO biomarker • Metastases • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS

a Study to Evaluate the Safety and Efficacy of D-1553 Combined With IN10018 in KRAS G12C Mutant Solid Tumors (clinicaltrials.gov) - P1/2 | N=140 | Active, not recruiting | Sponsor: InxMed (Shanghai) Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS

Phase II Neoadjuvant Study of Garsorasib Followed by Ivonescimab Plus Chemotherapy in Resectable Stage IIA-IIIB KRAS G12C-Mutant NSCLC (GIVEN Study) (clinicaltrials.gov) - P2 | N=32 | Not yet recruiting | Sponsor: Guangdong Provincial People's Hospital

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS

A Phase 3 Study of IN10018 in Combination With D-1553 Versus Standard Therapy for First Line Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (clinicaltrials.gov) - P3 | N=400 | Recruiting | Sponsor: InxMed (Shanghai) Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS

a Study to Evaluate the Safety and Efficacy of D-1553 Combined With IN10018 in KRAS G12C Mutant Solid Tumors (clinicaltrials.gov) - P1/2 | N=140 | Recruiting | Sponsor: InxMed (Shanghai) Co., Ltd. | Trial completion date: Dec 2026 ➔ Dec 2028 | Trial primary completion date: Dec 2025 ➔ Dec 2027

Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS

Phase 2 Clinical Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of GH21 Capsules Combined With D-1553 Tablets in Subjects With Locally Advanced or Metastatic Solid Tumors With the KRASG12C Mutation (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: Suzhou Genhouse Bio Co., Ltd.

New P2 trial • Solid Tumor • KRAS

Garsorasib In KRAS G12C Mutant Locally Advanced and Metastatic NSCLC (clinicaltrials.gov) - P2 | N=69 | Not yet recruiting | Sponsor: Sun Yat-sen University

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS

Efficacy and safety of garsorasib in patients with KRAS G12C-mutated advanced pancreatic cancer. (PubMed, Br J Cancer) - P1/2 | "Garsorasib demonstrated encouraging antitumor activity and a tolerable safety profile in patients with KRAS G12C-mutated advanced pancreatic cancer."

Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS

Garsorasib in patients with KRAS G12C-mutated non-small-cell lung cancer: A pooled analysis of phase 1/2 study. (PubMed, Eur J Cancer) - P1/2 | "This pooled analysis confirmed the robust efficacy and manageable safety of garsorasib in KRAS G12C-mutated NSCLC."

Journal • P1/2 data • Retrospective data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS