KRAS Inhibitors for Cancer Treatment

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SUMMARY

Revolution Medicines' daraxonrasib (RMC-6236) received FDA Orphan Drug Designation for pancreatic cancer on June 28, 2026, and the FDA accepted a New Drug Application for it on July 22, 2026, including it in a priority voucher program. As of July 22, 2026, several KRAS inhibitors are advancing, with Verastem Oncology dosing the first patient in a new Phase 2 trial for VS-7375 targeting KRAS G12D-mutated NSCLC and initiating trials for pancreatic and colorectal cancers. Zoldonrasib received FDA Breakthrough Therapy Designation for KRAS G12D-mutant NSCLC on July 16, 2026, showing a 30% response rate in previously treated pancreatic cancer. Roche's divarasib demonstrated superiority in the Phase III Krascendo 1 trial against Amgen's Lumakras and Bristol Myers Squibb's Krazati for NSCLC on July 2, 2026, meeting primary and key secondary endpoints for progression-free and overall survival. Incyte's INCB161734 showed a 34% chance of significant tumor shrinkage in pancreatic ductal adenocarcinoma patients in early Phase 1 results on July 1, 2026.

Timeline

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July 2026 — 7 developments

  1. New KRAS Inhibitor Trials Launched; Daraxonrasib Receives FDA Review for Pancreatic Cancer

    Verastem Oncology has dosed the first patient in a new Phase 2 trial for VS-7375 targeting KRAS G12D-mutated NSCLC and initiated trials for pancreatic and colorectal cancers. The FDA has accepted a New Drug Application for daraxonrasib (RMC-6236) for pancreatic cancer and included it in a priority voucher program. Incyte will present new Phase 1 data for its KRAS G12D inhibitor INCB161734 and is recruiting for a Phase 3 trial.

  2. KRAS Inhibitor Data Presentations Scheduled; Daraxonrasib Shows Survival Benefit

    Incyte will present new Phase 1 data for its KRAS G12D inhibitor INCB161734 at the ESMO Congress 2026 in October. Erasca announced updated preliminary Phase 1 data for its pan-RAS molecular glue ERAS-0015 and outlined clinical development plans. Revolution Medicines presented pivotal Phase 3 RASolute-302 trial results for daraxonrasib (RMC-6236), demonstrating a statistically significant overall survival benefit in previously treated metastatic pancreatic cancer.

  3. New KRAS Inhibitors Zoldonrasib and Elisrasib Receive FDA Designations for Cancer Treatment

    Zoldonrasib has received FDA Breakthrough Therapy Designation for KRAS G12D-mutant NSCLC and shown a 30% response rate in previously treated KRAS G12D-mutated pancreatic cancer. Elisrasib has demonstrated promising response rates in advanced NSCLC patients, including those with prior KRAS G12C inhibitor treatment, and received FDA Fast Track and Breakthrough Therapy designations.

  4. Revolution Medicines Initiates EMA Phased Review for Daraxonrasib, Nears FDA Submission

    Revolution Medicines has initiated a phased review of its RAS(ON) multi-selective inhibitor, daraxonrasib (RMC-6236), with the European Medicines Agency (EMA) for previously treated metastatic pancreatic ductal adenocarcinoma. The company is also nearing completion of its rolling New Drug Application (NDA) to the U.S. FDA.

  5. Revolution Medicines Presents Combination Therapy Data; Verastem Oncology Advances VS-7375 Trials

    Revolution Medicines presented early-stage data showing a 50% objective response rate (ORR) for a combination of zoldonrasib and daraxonrasib in second-line mPDAC patients. Verastem Oncology has initiated three registration-directed Phase 2 studies for its KRAS G12D inhibitor VS-7375 and plans to discuss Phase 3 trial designs with the FDA by the end of 2026.

  6. Roche's Divarasib Outperforms Rivals in NSCLC Trial; Verastem's VS-7375 Gets FDA Fast Track

    Roche's investigational KRAS G12C inhibitor, divarasib, has demonstrated superiority in the Phase III Krascendo 1 trial against Amgen's Lumakras and Bristol Myers Squibb's Krazati for NSCLC, meeting primary and key secondary endpoints for progression-free survival and overall survival. Verastem Oncology's VS-7375 has received FDA Fast Track Designation for KRAS G12D-mutated NSCLC.

  7. Incyte's INCB161734 Shows Tumor Shrinkage in Pancreatic Cancer; Phase III Trial Planned

    Incyte's INCB161734, a KRAS G12D inhibitor, has shown a 34% chance of significant tumor shrinkage in patients with pancreatic ductal adenocarcinoma at a 1,200 mg daily dose in early Phase 1 results. A global Phase III DAWN-303 trial is planned to enroll patients with previously untreated metastatic pancreatic ductal adenocarcinoma.

June 2026 — 5 developments

  1. Daraxonrasib Receives FDA Orphan Drug Designation for Pancreatic Cancer Treatment

    Revolution Medicines' daraxonrasib (RMC-6236) has received FDA Orphan Drug Designation for the treatment of pancreatic cancer. The drug has previously shown significant promise in clinical trials, demonstrating improvements in progression-free survival and overall survival benefit compared to standard chemotherapy.

  2. Revolution Medicines to Seek Expedited FDA Approval for Pancreatic Cancer Drug Daraxonrasib

    Revolution Medicines plans to file for expedited regulatory approval for daraxonrasib (RMC-6236) under a new FDA pilot program. The drug has shown significant promise in clinical trials for pancreatic cancer, nearly doubling overall survival and reducing the risk of death by 60%.

  3. Verastem Oncology to Initiate Phase 3 Trials for VS-7375 in 2027 After Promising Early Data

    Verastem Oncology plans to complete Phase 2 enrollment for VS-7375 in 2026 and initiate Phase 3 pivotal trials in 2027, following encouraging preliminary findings from its TARGET-D 101 Phase 1/2 trial. As of June 12, 2026, 93% of metastatic pancreatic cancer patients at the 900 mg QD dose achieved a reduction of more than 50% in the tumor marker CA19-9.

  4. FDA Grants Breakthrough Therapy Designation to Daraxonrasib for Pancreatic Cancer

    Revolution Medicines received FDA Breakthrough Therapy Designation for daraxonrasib (RMC-6236) for pancreatic cancer, following trial results showing significant improvements in overall survival. Verastem Oncology initiated Phase 2 registration-directed trials for VS-7375, showing anti-tumor activity. Incyte presented updated data from a Phase 1b study of INCB161734, demonstrating a manageable safety profile and anti-tumor activity. Mirati Therapeutics terminated an early-phase trial of MRTX1133 due to formulation challenges.

  5. FDA Grants Fast Track Designation to Verastem's VS-7375; Daraxonrasib Shows Survival Benefit

    Verastem Oncology's VS-7375 has received FDA Fast Track Designation for KRAS G12D-mutated non-small cell lung cancer. Revolution Medicines' daraxonrasib (RMC-6236) demonstrated doubled overall survival and progression-free survival in a Phase 3 trial for metastatic pancreatic cancer. These developments mark significant progress in the treatment of KRAS-mutated cancers.

May 2026 — 6 developments

  2. Incyte Launches Phase 3 Trial for INCB161734; MRTX1133 Trials Halted

    Incyte has initiated the Phase 3 DAWN-303 trial to evaluate INCB161734 in combination with chemotherapy for patients with KRAS G12D-mutated metastatic pancreatic cancer. Separately, clinical trials for the KRAS G12D selective inhibitor MRTX1133 were terminated in March 2025 due to formulation challenges and highly variable pharmacokinetics.

  3. FDA allows expanded access for RMC-6236; new KRAS inhibitor setidegrasib shows early promise

    The FDA has issued a 'safe to proceed' letter for RMC-6236 (daraxonrasib), allowing an expanded access treatment protocol for patients with previously treated metastatic pancreatic ductal adenocarcinoma. Revolution Medicines plans to submit a new drug application for daraxonrasib. Separately, setidegrasib, a targeted therapy that degrades the KRAS G12D protein, has shown encouraging early activity and tumor shrinkage in patients with advanced lung and pancreatic cancers.

  4. MRTX1133 Shows Preclinical Promise in Pancreatic Cancer; Elisrasib Effective in Lung Cancer

    MRTX1133, a KRAS G12D inhibitor, has demonstrated promising preclinical results in shrinking or halting tumor growth in mouse models for pancreatic cancer. Research also suggests MRTX1133 may synergize with immunotherapy and other agents. Separately, next-generation KRAS G12C inhibitors like elisrasib are showing promising response rates in advanced lung cancer patients.

  5. Incyte's INCB161734 Initiates Phase 3 Trial for Pancreatic Cancer Amidst Hold Clarification

    Incyte's KRAS G12D inhibitor, INCB161734, has entered pivotal development with the initiation of a Phase 3 study (Dawn-03) for first-line treatment of KRAS G12D-mutant pancreatic cancer. Patient recruitment is active in the U.S., Australia, and Japan. Incyte stated the hold on its Phase 1 trial in Europe due to a fatal pneumonitis case was administrative, as no causal relationship was found.

  6. FDA Clears VS-7375 IND; Bristol Myers Squibb Reportedly Exits MRTX1133 Development

    The FDA has cleared the Investigational New Drug (IND) application for VS-7375, an oral inhibitor targeting KRAS G12D mutations, allowing for clinical trials in the US. Separately, Bristol Myers Squibb has reportedly exited the development of MRTX1133, a KRAS G12D inhibitor, despite its acquisition of Mirati Therapeutics.

April 2026 — 6 developments

  1. KRAS Inhibitors Daraxonrasib and INCB161734 Advance in Pancreatic Cancer Trials

    Daraxonrasib (RMC-6236) has shown antitumor activity and disease control as a first-line treatment for metastatic pancreatic ductal adenocarcinoma (PDAC), outperforming historical chemotherapy benchmarks and receiving Orphan Drug Designation. Incyte has advanced INCB161734 into pivotal development with the initiation of the Dawn-03 trial for KRAS G12D-mutant pancreatic cancer, despite earlier toxicity concerns.

  2. Daromakrasib shows significant overall survival benefit in pancreatic cancer trial

    Daromakrasib (RMC-6236) has demonstrated a significant overall survival benefit in a Phase 3 trial for metastatic pancreatic cancer, nearly doubling median OS compared to standard chemotherapy and reducing the risk of death by 60%. Additionally, INCB161734 has shown antitumor activity in KRAS G12D-mutated PDAC, prompting the planning of a global Phase III trial.

  3. FDA Grants Fast Track Designation to Verastem Oncology's VS-7375 for Pancreatic Cancer

    The FDA has granted Fast Track Designation to Verastem Oncology's oral KRAS G12D inhibitor, VS-7375, for pancreatic cancer. Separately, the clinical trial for MRTX1133, another KRAS G12D inhibitor, was terminated due to formulation and pharmacokinetic issues. Research continues with Ensem Therapeutics' ETX-929 and Adlai Nortye's new inhibitors.

  4. Revolution Medicines announces positive Phase III results for daraxonrasib in pancreatic cancer

    Revolution Medicines announced positive topline Phase III results for daraxonrasib (RMC-6236) in metastatic pancreatic cancer, demonstrating a median overall survival of 13.2 months, nearly doubling that of standard chemotherapy. Incyte's INCB161734 is on a temporary clinical hold due to a Grade 5 pneumonitis case.

  5. New pan-KRAS inhibitors BI-2865 and BI-2493 demonstrate potent and reversible inhibition

    New pan-KRAS inhibitors BI-2865 and BI-2493 are demonstrating potent and reversible inhibition, while a uniquely engineered RNA drug targeting KRAS G12V is in preclinical studies.

  6. Setidegrasib shows encouraging responses in lung and pancreatic cancer patients

    Phase 1 clinical trial results for setidegrasib, a KRAS degrader targeting the G12D mutation, have been published, showing encouraging responses in lung and pancreatic cancer patients. Researchers are also exploring new pan-KRAS inhibitors, and Penn Medicine plans to investigate pan-RAS inhibitors for precancerous pancreatic lesions.

March 2026 — 10 developments

  1. Revolution Medicines to Present New Phase 1 Data for Zoldonrasib at AACR Annual Meeting

    Revolution Medicines will present new Phase 1 data for zoldonrasib (RMC-9805), a selective inhibitor for KRAS G12D mutant non-small cell lung cancer, at the AACR Annual Meeting in April 2026. Findings from Phase 1/2 studies on daraxonrasib (RMC-6236), a multi-selective inhibitor for metastatic pancreatic ductal adenocarcinoma, will also be featured, alongside preclinical research on new RAS(ON) inhibitors.

  2. INCB161734 shows promise in pancreatic cancer, BlossomHill and D3 Bio develop new inhibitors

    INCB161734, a KRAS G12D inhibitor, has shown promising results in advanced pancreatic cancer patients, with some experiencing disease control and objective responses, though a clinical hold was noted due to pneumonitis. BlossomHill Therapeutics and D3 Bio are developing next-generation pan-KRAS inhibitors targeting various mutations, showing potent inhibition in preclinical studies.

  3. Bristol Myers Squibb discontinues development of cancer drug MRTX1133

    Bristol Myers Squibb has discontinued the development of MRTX1133, a selective oral KRAS G12D inhibitor, despite no safety concerns being identified. The decision was reportedly influenced by pharmacokinetic factors. This marks a significant shift in the clinical progression of this investigational cancer therapy.

  4. MRTX1133 demonstrates preclinical antitumor efficacy, enters clinical trial

    MRTX1133, a selective KRAS G12D inhibitor, has demonstrated potent preclinical antitumor efficacy, particularly in pancreatic ductal adenocarcinoma. Research is focused on combining MRTX1133 with chemotherapy to reduce tumor growth and overcome resistance, with a phase I/II clinical trial underway.

  5. Revolution Medicines' Daraxonrasib shows early activity in pancreatic cancer, receives FDA breakthrough designation

    Revolution Medicines' investigational pan-RAS inhibitor, Daraxonrasib (RMC-6236), has demonstrated early activity and a manageable safety profile in patients with RAS-mutant pancreatic adenocarcinoma. The drug has received FDA breakthrough therapy designation for previously treated metastatic PDAC with KRAS G12X mutations, and a Phase 3 trial is underway.

  6. Verastem Oncology's VS-7375 shows promising safety and antitumor activity in solid tumors

    Verastem Oncology's investigational oral KRAS G12D inhibitor VS-7375 demonstrated a promising early safety profile and preliminary antitumor activity in patients with advanced solid tumors harboring a KRAS G12D mutation. In the Phase 1/2a VS-7375-101 trial, no dose-limiting toxicities were observed at daily doses of 400 mg and 600 mg, and 80% of efficacy-evaluable patients experienced tumor reduction. The FDA granted VS-7375 Fast Track Designation in July 2025 for KRAS G12D-mutated pancreatic cancer.

  7. Verastem Oncology outlines new development pathway for KRAS G12D inhibitor VS-7375

    Verastem Oncology has outlined a new development pathway for its KRAS G12D inhibitor, VS-7375, for pancreatic, colorectal, and non-small cell lung cancer, following discussions with the US Food and Drug Administration. The investigational oral inhibitor has demonstrated a promising early safety profile and preliminary antitumor activity in pretreated patients with advanced solid tumors harboring a KRAS G12D mutation.

  8. Incyte's KRAS G12D Inhibitor Placed on Clinical Hold in Europe After Patient Death

    Incyte's KRAS G12D inhibitor, INCB161734, has been placed on clinical hold in four European countries following a Grade 5 pneumonitis death in a participant. Three additional cases of pneumonitis were also reported, all associated with the 1.2g dose.

  9. INCB161734 shows disease control in pancreatic cancer; Verastem's VS-7375 advances

    The KRAS G12D inhibitor INCB161734 demonstrated disease control in nearly 80% of heavily pretreated advanced pancreatic cancer patients, with 37% achieving objective responses. Verastem Oncology's inhibitor VS-7375 has cleared multiple dose levels in early studies without dose-limiting toxicities, allowing for continued dose escalation. Additionally, Erasca and Tango Therapeutics are collaborating to evaluate a combination therapy for RAS-mutant cancers.

  10. Verastem Oncology reports oral KRAS inhibitor VS-7375 cleared early studies

    A PNAS study published on December 2, 2025, details a triple combination therapy involving daraxonrasib that induced complete regression of pancreatic cancer tumors in mice with no evidence of resistance. Verastem Oncology reported on March 4, 2026, that their oral KRAS G12D inhibitor VS-7375 cleared multiple dose levels in early studies without dose-limiting toxicities, allowing dose escalation to continue.

February 2026 — 4 developments

  1. Erasca Presents Updates on Pan-RAS and Pan-KRAS Inhibitors, ERAS-0015 Shows Potency Advantage

    Erasca presented updates on its pan-RAS inhibitor ERAS-0015 and pan-KRAS inhibitor ERAS-4001, with ERAS-0015 showing a potency advantage over RMC-6236. Separately, a PNAS study details a triple combination therapy including daraxonrasib that induced complete regression of pancreatic cancer tumors in mice with no evidence of resistance.

  2. INCB161734 shows promising disease control rates in pancreatic cancer at ASCO GI 2026

    Preliminary Phase 1 data for INCB161734 presented at ASCO GI 2026 showed a disease control rate of 73% at 600 mg once daily and 86% at 1200 mg once daily in patients with advanced pancreatic cancer. New research also suggests combining chemotherapy with KRAS inhibitors may enhance treatment effectiveness, and that resistance to KRAS G12D inhibitors can be overcome by BET inhibition.

  3. Incyte plans Phase 3 trial for KRAS G12D inhibitor INCB161734 in Q1 2026

    Incyte has announced that based on positive clinical data from a Phase 1 trial of INCB161734 in patients with advanced pancreatic ductal adenocarcinoma, a Phase 3 study is expected to commence in the first quarter of 2026. This marks a significant step forward in the development of this KRAS G12D inhibitor.

  4. Verastem Oncology to Report Interim Update on VS-7375 Phase 1/2 Trial in First Half of 2026

    Verastem Oncology is advancing its clinical development program for VS-7375, a selective oral KRAS G12D inhibitor, and expects to report an interim update on its Phase 1/2 trial in the first half of 2026. Early data for INCB161734 show a manageable safety profile and evidence of antitumor activity in heavily pretreated patients with KRAS G12D-mutated PDAC. Additionally, the investigational oral KRAS G12D inhibitor VS-7375 has demonstrated a promising early safety profile and preliminary antitumor activity in pretreated patients with advanced solid tumors harboring a KRAS G12D mutation.

January 2026 — 9 developments

  3. Study reports triple-targeted drug combination regresses pancreatic tumors in preclinical models

    A new study reported that a triple-targeted drug combination, including the KRAS inhibitor daraxonrasib, achieved complete and lasting regression of pancreatic tumors in preclinical models, demonstrating potential to overcome treatment resistance.

  4. Research links KRAS G12D inhibitor resistance to BET inhibition sensitivity

    Research indicates that resistance to the KRAS G12D inhibitor MRTX1133 is associated with increased sensitivity to BET inhibition, with murine models showing that BET inhibition cooperated with MRTX1133 to significantly extend overall survival.

  5. Incyte and Revolution Medicines Announce Positive Pancreatic Cancer Drug Developments

    Preliminary Phase 1 results for Incyte's oral KRAS G12D inhibitor INCB161734 showed promising early clinical efficacy and molecular response in advanced pancreatic cancer patients, with common side effects being nausea and diarrhea. Revolution Medicines' daraxonrasib (RMC-6236) received Orphan Drug Designation from the FDA for pancreatic cancer treatment, building on promising safety and efficacy data from its Phase 1/1b trial.

  6. INCB161734 shows manageable safety and promising efficacy in pancreatic cancer

    Preliminary Phase 1 results for INCB161734, an oral KRAS G12D inhibitor, show a manageable safety profile with mostly grade 1/2 adverse events in patients with advanced pancreatic ductal adenocarcinoma. Updated data from a Phase 1 study presented at ASCO GI indicated a 78% disease control rate and a 37% objective response rate among evaluable patients. Additionally, VS-7375 has received Fast Track Designation from the FDA for KRAS G12D-mutated advanced pancreatic cancer.

  7. Daraxonrasib Receives FDA Breakthrough Therapy Designation for Pancreatic Cancer

    Daraxonrasib received FDA breakthrough therapy designation for treating metastatic pancreatic cancer with KRAS G12X mutations. Separately, preliminary clinical data for INCB161734 showed nearly 80% disease control in heavily pretreated advanced pancreatic cancer patients.

  8. Incyte Reports Promising Early Efficacy for Oral KRAS G12D Inhibitor in Advanced Solid Tumors

    Incyte's oral KRAS G12D inhibitor, INCB161734, has shown a manageable safety profile and promising early efficacy in patients with advanced solid tumors, including KRAS G12D-mutated pancreatic ductal adenocarcinoma. A Phase 1 study reported a disease control rate of 78% for the investigational drug.

  9. INCB161734 shows manageable safety profile in early clinical data for pancreatic cancer

    Early clinical data for INCB161734, a novel oral KRAS G12D inhibitor, presented at ASCO GI 2026, shows a manageable safety profile as monotherapy and in combination with chemotherapy for patients with advanced pancreatic ductal adenocarcinoma.

November 2025 — 1 developments

  1. Revolution Medicines reports positive Phase 1 trial results for zoldonrasib in KRAS G12D-mutant cancers

    MRTX1133, a KRAS G12D inhibitor, has advanced to Phase 1 clinical trials, showing tumor shrinkage in four out of five patients with advanced KRAS G12D-mutant cancers. Revolution Medicines reported that its KRAS G12D-selective inhibitor, zoldonrasib (RMC-9805), has demonstrated encouraging safety and antitumor activity in patients with previously treated non-small cell lung cancer.

October 2025 — 3 developments

  1. Review highlights shift to G12D and pan-RAS inhibitors in pancreatic cancer drug development

    A comprehensive review of KRAS drug development in pancreatic cancer highlighted the shift towards G12D inhibitors like MRTX1133 and pan-RAS inhibitors like daraxonrasib, with numerous agents in clinical trials.

  2. Verastem's KRAS G12D inhibitor VS-7375 shows 41% response rate in pancreatic cancer trial

    Verastem's KRAS G12D inhibitor VS-7375 demonstrated a 41% overall response rate in a clinical trial with heavily pre-treated pancreatic cancer patients, with 91.5% experiencing disease control. Separately, a new study suggests resistance to MRTX1133 is associated with increased sensitivity to BET inhibition, with combination therapy showing extended survival in murine models.

  3. Incyte presents positive preliminary Phase 1 data for KRAS inhibitor INCB161734 in pancreatic cancer

    Incyte presented preliminary Phase 1 data for its KRAS G12D inhibitor, INCB161734, in advanced pancreatic ductal adenocarcinoma, with a data cut-off of August 1, 2025. The data showed evidence of clinical benefit in 83 patients and a manageable safety profile with mostly Grade 1 gastrointestinal toxicities. The trial is ongoing, with results expected in 2026.

August 2025 — 1 developments

  1. Review Article Highlights KRAS Role in Pancreatic Cancer, Citing Inhibitor Approvals

    A review article emphasized the critical role of KRAS in pancreatic cancer and noted that the recent approval of KRAS inhibitors for other cancers has shattered the "undruggable" perception, fueling hope for breakthroughs in PDAC therapy.

July 2025 — 3 developments

  1. Revolution Medicines Announces Positive Phase 3 Results for Daraxonrasib in Pancreatic Cancer

    Revolution Medicines announced topline results from the Phase 3 RASolute 302 trial for daraxonrasib (RMC-6236) in patients with metastatic pancreatic ductal adenocarcinoma. The trial demonstrated statistically significant improvements in overall survival and progression-free survival compared to standard-of-care chemotherapy. The company plans to submit these data to regulatory authorities and present them at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting.

  2. Verastem Oncology's VS-7375 receives FDA Fast Track designation for pancreatic cancer

    Verastem Oncology's oral KRAS G12D inhibitor, VS-7375, received FDA Fast Track designation for locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) with KRAS G12D mutation, for both first-line treatment and after prior systemic therapy.

  3. MRTX1133 discontinued from Phase 1 trials; Daraxonrasib shows encouraging early results

    MRTX1133, a reversible KRAS G12D inhibitor, was discontinued from Phase 1 trials in March 2025 due to formulation challenges and suboptimal pharmacokinetics. Additionally, Daraxonrasib (RMC-6236), a pan-RAS(ON) inhibitor, is showing encouraging early clinical results for RAS-driven cancers and is undergoing a large international Phase 3 trial.

May 2025 — 1 developments

  1. VS-7375 shows 52% overall response rate in advanced solid tumors at ASCO Annual Meeting

    Initial safety and efficacy findings for VS-7375 in advanced solid tumors, including PDAC, were presented at the ASCO Annual Meeting, showing a 52% overall response rate and 100% disease control rate in PDAC patients with KRAS G12D mutation.

April 2025 — 1 developments

  1. FDA approves investigational new drug application for VS-7375 for advanced solid tumors

    The FDA approved an investigational new drug (IND) application for VS-7375, an oral KRAS G12D inhibitor, for the treatment of patients with advanced solid tumors, including pancreatic cancer.

August 2024 — 1 developments

  1. Chemotherapy enhances KRAS inhibitors in pancreatic cancer by shutting down cellular instructions

    Further research highlighted that chemotherapy could enhance the effectiveness of KRAS inhibitors in pancreatic cancer by shutting down different cellular instructions that drive cancer cell growth, potentially preventing resistance.

July 2024 — 1 developments

  1. Memorial Sloan Kettering Researchers Identify KRAS Inhibitor Resistance Mechanism in Pancreatic Cancer

    Memorial Sloan Kettering Cancer Center researchers published findings on a new mechanism of resistance to KRAS inhibitors in pancreatic cancer models, identifying opportunities to improve treatment effectiveness, particularly for the aggressive 'basal' subtype.

June 2024 — 1 developments

  1. Studies show KRAS inhibitors with chemotherapy reduce pancreatic tumor growth in mice

    Studies published in Cancer Discovery demonstrated that combining chemotherapy with experimental KRAS inhibitors, such as MRTX1133, significantly reduced tumor growth and spread in mouse models of pancreatic cancer, suggesting a strategy to overcome resistance.

October 2023 — 1 developments

  1. Revolution Medicines Presents Promising RMC-6236 Data in Lung and Pancreatic Cancers

    Revolution Medicines presented promising anti-tumor and safety data for its RAS inhibitor RMC-6236 in patients with previously treated non-small cell lung cancer and pancreatic ductal adenocarcinoma. In 40 efficacy-evaluable NSCLC patients, the objective response rate was 38% and the disease control rate was 85%. For pancreatic ductal adenocarcinoma patients, median progression-free survival was 8.5 months and median overall survival was 14.5 months.

January 2023 — 2 developments

  1. Mirati Therapeutics receives FDA clearance for IND application of KRASG12D inhibitor MRTX1133

    Mirati Therapeutics announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for MRTX1133, a potential first-in-class oral KRASG12D selective inhibitor. This clearance allows for the initiation of Phase 1 clinical evaluation of MRTX1133, which targets KRASG12D mutations found in approximately 180,000 patients in the US and Europe, for whom there are currently no targeted treatment options.

  2. G12C inhibitors show limited applicability in pancreatic cancer due to rare mutation

    Despite the success of G12C inhibitors in lung cancer, it became clear that these drugs had limited applicability in pancreatic cancer, where the G12C mutation is rare (1-2% of cases), shifting research focus to other prevalent mutations like G12D.

December 2022 — 1 developments

  1. FDA grants accelerated approval to Adagrasib for NSCLC

    Adagrasib (Krazati), another KRAS G12C inhibitor, received accelerated FDA approval for NSCLC, further expanding treatment options for this specific KRAS mutation.

May 2021 — 1 developments

  1. FDA approves Sotorasib (Lumakras) for non-small cell lung cancer

    Sotorasib (Lumakras), the first KRAS G12C inhibitor, received accelerated FDA approval for treating non-small cell lung cancer (NSCLC), validating the concept of directly targeting KRAS mutations.

January 2013 — 1 developments

  1. Discovery of KRAS G12C allosteric site enables direct KRAS inhibitor development

    After decades of KRAS being considered "undruggable," a pivotal discovery was made regarding a cryptic allosteric site in KRAS G12C, opening the door for the development of direct KRAS inhibitors.