Safety

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The FDA defines ARs as any undesirable effects reasonably associated with use of a drug. TRAEs, however, were investigator-assessed as related to use of a drug. As a result, there may be discrepancies in the values reported for ARs and TRAEs.^3,4

*ARs leading to permanent discontinuation of RASONQUE occurred in 2.9% of patients, including 2 patients who discontinued due to rash (0.8%).¹

^†Three patients (1.2%) who received RASONQUE had Grade 4 TRAEs: an increased AST level in 2 patients and a decreased platelet count in 1 patient.²

^‡In clinical trials of patients with metastatic pancreatic adenocarcinoma, 1 patient who received RASONQUE had a Grade 5 event of interstitial lung disease (ILD)/pneumonitis and 1 patient who received RASONQUE had a Grade 5 event of GI perforation.¹

^§Serious is defined as resulting in death, being life threatening, requiring inpatient hospitalization or prolongation of existing hospitalization, resulting in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or deemed serious by medical judgment.³

^llTwo patients had a maculo-papular rash of Grade 3, and 1 patient had an increased ALT level of Grade 3 and an increased AST level of Grade 4.²

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*Graded per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.¹

^†Safety assessments for patients receiving RASONQUE were performed every 2 weeks or more frequently at the investigator’s discretion.³

^‡Prophylaxis guidelines are available to help support rash management.

^§Includes multiple related terms.¹

^||Hemorrhage consists of multiple related terms. In the RASONQUE arm of RASolute 302, 22% of patients experienced hemorrhage of any grade. 9.5% of hemorrhage was Grade 1 epistaxis. Grade 3 or higher GI hemorrhage events were reported in 6/241 (2.5%) of patients total: gastric (n=1), GI (n=2), rectal (n=1), and small intestinal (n=2). No CNS hemorrhages were reported in the RASONQUE arm of the study.⁵

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*The denominator used to calculate the percentage varied from 234 to 237 in the RASONQUE arm and from 207 to 208 in the SOC chemotherapy arm, based on the number of patients with a baseline value and at least one post-baseline value.¹

^†Graded per NCI CTCAE Version 5.0.¹

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ALT=alanine aminotransferase; AST=aspartate aminotransferase; CNS=central nervous system; GI=gastrointestinal; SOC=standard of care; TRAEs=treatment-related adverse events.

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References: 1. RASONQUE. Prescribing information. Revolution Medicines, Inc.; 2026. 2. O’Reilly EM, Wainberg ZA, Hendifar AE, et al; RASolute 302 Trial Investigators. Daraxonrasib or chemotherapy in previously treated metastatic pancreatic cancer. N Engl J Med. Published online May 31, 2026. doi:10.1056/NEJMoa2605555 3. Protocol for: O’Reilly EM, Wainberg ZA, Hendifar AE, et al; RASolute 302 Trial Investigators. Daraxonrasib or chemotherapy in previously treated metastatic pancreatic cancer. N Engl J Med. Published online May 31, 2026. doi:10.1056/NEJMoa2605555 4. U.S. Food and Drug Administration. Adverse reactions section of labeling for human prescription drug and biological products — content and format. U.S. Department of Health and Human Services; 2026. Accessed August 10, 2026. https://www.fda.gov/media/72139/download 5. Data on file. Revolution Medicines, Inc.; 2026.

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