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Divarasib

Divarasib is an investigational drug being studied in several clinical trials for the treatment of advanced cancers, particularly non-small cell lung cancer (NSCLC) and colorectal cancer. These trials aim to evaluate the safety, efficacy, and pharmacokinetics of Divarasib, both as a single agent and in combination with other cancer therapies. The studies focus on patients with specific genetic mutations, such as KRAS G12C, and explore Divarasib’s potential in various treatment settings.

Table of Contents

What is Divarasib?

Divarasib is a new drug being studied for the treatment of certain types of cancer. It is also known by its alternative names RO7435846 and GDC-6036[5]. Divarasib belongs to a class of drugs called targeted therapies, which are designed to attack specific features of cancer cells while minimizing damage to healthy cells[4].

How Divarasib Works

Divarasib is specifically designed to target a particular genetic mutation called KRAS G12C. This mutation is found in some types of cancer and plays a role in helping cancer cells grow and survive. By targeting this mutation, Divarasib aims to slow down or stop the growth of cancer cells[2].

Conditions Treated by Divarasib

Based on the clinical trials information, Divarasib is being studied for the treatment of:

  • Non-Small Cell Lung Cancer (NSCLC): This is the most common type of lung cancer. Divarasib is being tested in patients with advanced or metastatic NSCLC that has the KRAS G12C mutation[2].
  • Metastatic Colorectal Cancer: Divarasib is also being studied in patients with colorectal cancer that has spread to other parts of the body (metastatic) and has specific biomarkers[4].

Clinical Trials Involving Divarasib

Several clinical trials are currently underway to evaluate the effectiveness and safety of Divarasib:

  • Phase III trial for NSCLC: This large-scale study is comparing Divarasib to other KRAS G12C inhibitors (sotorasib or adagrasib) in patients with previously treated NSCLC[2].
  • Drug interaction studies: Researchers are investigating how Divarasib interacts with other medications, such as itraconazole, digoxin, and rosuvastatin[1][3].
  • Combination therapy studies: Divarasib is being tested in combination with other cancer treatments, including immunotherapy drugs like atezolizumab and chemotherapy drugs[4].
  • Early-stage NSCLC study: A trial is evaluating Divarasib as a treatment before and after surgery for patients with early-stage NSCLC[6].

How Divarasib is Administered

Divarasib is typically taken orally (by mouth) once daily. The exact dosage and schedule may vary depending on the specific clinical trial and the patient’s condition[2]. In some studies, Divarasib is given in combination with other cancer treatments, such as chemotherapy or immunotherapy[4].

Potential Side Effects

As with all medications, Divarasib may cause side effects. The full range of potential side effects is still being studied in clinical trials. Common side effects observed in cancer treatments may include fatigue, nausea, diarrhea, and decreased appetite. Researchers are closely monitoring patients for any adverse events during the clinical trials[2][6].

Future Prospects for Divarasib

Divarasib is still in the experimental stage and is not yet approved for general use. The ongoing clinical trials will help determine its effectiveness and safety profile. If the results are positive, Divarasib could become an important new treatment option for patients with KRAS G12C-mutated cancers, particularly in lung and colorectal cancer[2][4].

It’s important to note that while Divarasib shows promise, more research is needed to fully understand its benefits and risks. Patients interested in this treatment should discuss it with their healthcare providers and consider participating in clinical trials if eligible.

Aspect Details
Drug Name Divarasib (also known as GDC-6036)
Cancer Types Non-small cell lung cancer (NSCLC), Metastatic colorectal cancer
Target Population Patients with KRAS G12C mutations, Previously treated and untreated patients
Administration Oral, once daily
Study Types Phase 1, Phase 2, Phase 3 clinical trials
Combination Therapies Cetuximab, Bevacizumab, FOLFOX, FOLFIRI, Pembrolizumab
Primary Outcomes Safety, Efficacy (Objective Response Rate, Progression-Free Survival)
Secondary Outcomes Duration of Response, Overall Survival, Quality of Life measures

FAQ

  • What is Divarasib? Divarasib is an investigational drug being studied for the treatment of advanced cancers, particularly non-small cell lung cancer (NSCLC) and colorectal cancer. It is designed to target specific genetic mutations, such as KRAS G12C.
  • What types of cancer is Divarasib being studied for? Divarasib is primarily being studied for advanced or metastatic non-small cell lung cancer (NSCLC) and metastatic colorectal cancer. The trials focus on patients with specific genetic mutations, such as KRAS G12C.
  • How is Divarasib administered? In the clinical trials, Divarasib is typically administered orally (by mouth) once daily. The exact dosage and schedule may vary depending on the specific trial and treatment combination.
  • What are the potential side effects of Divarasib? While specific side effects are not detailed in the provided information, the clinical trials are designed to evaluate the safety of Divarasib. Common measures include monitoring for adverse events and assessing the percentage of participants experiencing side effects.
  • Is Divarasib used alone or in combination with other treatments? Divarasib is being studied both as a single agent and in combination with other cancer therapies. Some trials are exploring its use with drugs like cetuximab, bevacizumab, and chemotherapy regimens such as FOLFOX and FOLFIRI.

Ongoing Clinical Trials on Divarasib

  • Study of divarasib and pembrolizumab compared to standard chemotherapy in previously untreated KRAS G12C-mutated advanced non-small cell lung cancer

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Denmark France Germany Greece Hungary +6

  • Study on the Safety and Effects of Divarasib with Pembrolizumab and a Drug Combination for Patients with Advanced or Metastatic Non-Small Cell Lung Cancer with KRAS G12C Mutation

    Recruiting

    1 1 1 1
    Investigated drugs:
    Belgium Italy The Netherlands Poland Spain Sweden

  • Continued Cancer Treatment Study with Abiraterone, Ipatasertib, Tiragolumab, and Drug Combination for Patients from Previous Genentech/Roche Trials

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Greece Poland

  • Study on the Effectiveness of Inavolisib, Atezolizumab, and Entrectinib in Patients with Advanced or Metastatic Solid Tumors

    Not recruiting

    2 1 1 1
    Investigated drugs:
    Belgium Denmark France Germany Italy Poland +2

Glossary

  • Pharmacokinetics (PK): The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • KRAS G12C mutation: A specific genetic alteration in the KRAS gene, which is found in some types of cancer and can affect treatment response.
  • Metastatic: Cancer that has spread from its original site to other parts of the body.
  • Non-small cell lung cancer (NSCLC): A type of lung cancer that includes several subtypes, such as adenocarcinoma and squamous cell carcinoma.
  • Objective Response Rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.
  • Progression-Free Survival (PFS): The length of time during and after treatment that a patient lives with cancer without it worsening.
  • RECIST v1.1: Response Evaluation Criteria in Solid Tumors version 1.1, a standard way to measure how well a cancer patient responds to treatment.
  • Adverse Events (AEs): Any unfavorable and unintended sign, symptom, or disease associated with the use of a medical treatment.
  • FOLFOX: A combination chemotherapy regimen that includes folinic acid (leucovorin), fluorouracil, and oxaliplatin.
  • FOLFIRI: A combination chemotherapy regimen that includes folinic acid (leucovorin), fluorouracil, and irinotecan.

References

  1. https://clinicaltrials.gov/study/NCT06690138
  2. https://clinicaltrials.gov/study/NCT06497556
  3. https://clinicaltrials.gov/study/NCT06677957
  4. https://clinicaltrials.gov/study/NCT04929223
  5. https://clinicaltrials.gov/study/NCT03178552
  6. https://clinicaltrials.gov/study/NCT04302025