Sponsor: Hoffmann-La Roche (industry)
Phase: 3
Start date: Sept. 23, 2024
Planned enrollment: 320
Last updated in HealthScout: Dec 2024
Divarasib (also known as RG6330 or GDC-6036) is an investigational oral inhibitor targeting the KRAS G12C mutation, a common oncogenic driver in various solid tumors. (nejm.org)
Divarasib is a covalent inhibitor that binds irreversibly to the cysteine residue in the KRAS G12C mutant protein, locking it in its inactive GDP-bound state. This action prevents downstream oncogenic signaling pathways, thereby inhibiting tumor cell proliferation and survival. (nejm.org)
In a phase 1 clinical trial involving 137 patients with KRAS G12C-mutated advanced solid tumors, divarasib demonstrated notable antitumor activity:
Non–Small-Cell Lung Cancer (NSCLC): Among 60 patients, the confirmed objective response rate (ORR) was 53.4%, with a median progression-free survival (PFS) of 13.1 months. (nejm.org)
Colorectal Cancer (CRC): Among 55 patients, the confirmed ORR was 29.1%, with a median PFS of 5.6 months. (nejm.org)
Other Solid Tumors: Partial responses were observed in 36% of 22 patients with various other solid tumors, including pancreatic adenocarcinoma and cholangiocarcinoma. (nejm.org)
Divarasib was generally well-tolerated, with no dose-limiting toxicities reported. Treatment-related adverse events (TRAEs) occurred in 93% of patients, mostly grade 1 or 2. The most common TRAEs included nausea (74%), diarrhea (61%), and vomiting (58%). Grade 3 TRAEs were observed in 11% of patients, with no treatment-related deaths reported. (nejm.org)
Last updated: Apr 2025
As of April 30, 2025, the Phase III KRASCENDO 1 trial (NCT06497556) is actively comparing the efficacy and safety of divarasib against sotorasib and adagrasib in patients with previously treated KRAS G12C-positive advanced or metastatic non-small cell lung cancer (NSCLC). This trial is particularly significant due to divarasib's promising results in earlier studies and its potential to offer improved outcomes over existing treatments.
In a Phase I study, divarasib demonstrated a confirmed objective response rate of 53.4% among patients with NSCLC, with a median progression-free survival (PFS) of 13.1 months. These results suggest a potentially higher efficacy compared to existing KRAS G12C inhibitors. The safety profile of divarasib was manageable, with primarily low-grade gastrointestinal adverse effects that were reversible and manageable with supportive medications. (nejm.org)
The KRASCENDO 1 trial is noteworthy for its direct comparison of divarasib with the current standard-of-care agents, sotorasib and adagrasib. This head-to-head design is expected to provide clear insights into the relative efficacy and safety of these treatments, potentially influencing future therapeutic strategies for KRAS G12C-mutated NSCLC. Experts have highlighted the importance of such comparative trials in advancing treatment options. (onclive.com)
For oncologists and patients contemplating participation in the KRASCENDO 1 trial, the following points are pertinent:
Potential for Improved Outcomes: Early data suggest that divarasib may offer enhanced efficacy over existing treatments, which could translate to better patient outcomes.
Manageable Safety Profile: The adverse effects associated with divarasib have been primarily low-grade and manageable, indicating a favorable safety profile.
Contribution to Advancing Treatment: Participation in this trial contributes to the broader understanding of KRAS G12C inhibitors and their role in treating NSCLC, potentially benefiting future patients.
(nejm.org)
As the KRASCENDO 1 trial progresses, it is anticipated to provide valuable data that will inform the optimal use of KRAS G12C inhibitors in clinical practice.
Last updated: Apr 2025
Goal: To evaluate the safety and efficacy of divarasib in comparison to existing KRAS G12C inhibitors, sotorasib and adagrasib, in patients with previously treated advanced or metastatic non-small cell lung cancer (NSCLC) harboring the KRAS G12C mutation.
Patients: The trial studies patients with advanced or metastatic non-small cell lung cancer with a confirmed KRAS G12C mutation. Participants must have experienced disease progression during or after treatment with one to three lines of prior systemic therapies. They should have a life expectancy of at least 12 weeks and an ECOG performance status of 0 or 1.
Design: This is a phase III, randomized, open-label, multicenter study involving a planned enrollment of 320 participants. The trial will allocate patients to receive either the investigational drug divarasib or the standard treatments sotorasib or adagrasib.
Treatments: This trial examines divarasib, an investigational oral KRAS G12C inhibitor by Genentech/Roche. Divarasib operates by selectively targeting the KRAS G12C mutation, locking the protein in an inactive state and inhibiting tumor growth. In phase 1 trials, divarasib demonstrated substantial efficacy with a 56.4% objective response rate in NSCLC patients and a manageable safety profile, mostly consisting of low-grade gastrointestinal adverse effects. As comparators, participants will either receive sotorasib or adagrasib, both approved KRAS G12C inhibitors known for their demonstrated efficacy in reducing tumor size in this patient population.
Outcomes: The primary outcome is progression-free survival (PFS), measured from randomization until disease progression or death. Secondary outcomes include overall survival (OS), objective response rate, duration of response, and quality of life metrics assessing symptom treatment toxicity. The trial will observe adverse events and patient-reported outcomes to further determine efficacy and safety.
Burden on patient: The trial involves oral administration of medications, aligning with standard care practices and thus posing a low burden on patients. Regular assessments for disease progression and overall health status are expected, similar to routine clinical care for advanced NSCLC. The necessity for a tumor biopsy for mutation confirmation and the follow-up for adverse events may present some additional requirements, but these are minimal and standard in clinical trials aimed at prolonging life and managing cancer symptoms.
Inclusion Criteria:
* Unequivocal histologically or cytologically confirmed diagnosis of metastatic or locally advanced NSCLC not amenable to treatment with surgical resection or combined chemoradiation
* Disease progression during or after treatment with at least one prior systemic therapy but no more than three lines of prior systemic therapy in the advanced or metastatic setting
* Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
* Documentation of the presence of a KRAS G12C mutation
* Availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumor specimen in a paraffin block (preferred) or 10-15 (15 preferred) unstained, freshly cut, serial slides with an associated pathology report
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Life expectancy of \>= 12 weeks
Exclusion Criteria:
* Known hypersensitivity to any of the components of divarasib, or sotorasib or adagrasib
* Malabsorption syndrome or other condition that would interfere with enteral absorption
* Known concomitant second oncogenic driver
* Mixed small-cell lung cancer or large cell neuroendocrine histology
* Known and untreated, or active central nervous system (CNS) metastases
* Leptomeningeal disease or carcinomatous meningitis
* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures biweekly or more frequently
* Any infection that, in the opinion of the investigator, could impact patient safety, or treatment with therapeutic oral or IV antibiotics within 14 days prior to Day 1 of Cycle 1
* Prior treatment with any KRAS G12C inhibitor or pan-KRAS/RAS inhibitor
* More than 30 Gy of radiotherapy to the lung within 6 months of randomization
* Uncontrolled tumor-related pain
* Unresolved toxicities from prior anticancer therapy
* History of malignancy within 5 years prior to screening, with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate \>90%), such as adequately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer
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