The OncFive: Top Oncology Articles for the Week of 10/27

Welcome to OncLive®’s OncFive! Every week, we will compile the top 5 stories in oncology, ranging from pivotal regulatory decisions to news updates and expert interviews spanning tumor types.

Here’s what you may have missed this week:

FDA Grants Accelerated Approval to Asciminib for Newly Diagnosed Ph+ Chronic-Phase CML

Asciminib (Scemblix) received accelerated approval from the FDA for use in adult patients with newly diagnosed, Philadelphia chromosome–positive chronic myeloid leukemia in chronic phase (CP-CML) based on findings from the phase 3 ASC4FIRST trial (NCT04971226). Data showed that the major molecular response rate achieved with the agent (n = 201) at 48 weeks was 68% (95% CI, 61%-74%) vs 49% (95% CI, 42%-56%) with investigator’s choice of TKI (n = 204), which could have included imatinib (Gleevec), nilotinib (Tasigna), dasatinib (Sprycel), or bosutinib (Bosulif; difference, 19%; 95% CI, 10%-28%; P < .001).

RMC-9805 Triggers Tumor Regressions in KRAS G12D–Mutant Pancreatic Cancer

The oral RAS(ON) G12D-selective covalent inhibitor, RMC-9805, elicited an objective response rate of 30% with a disease control rate of 80% when given at a daily (n = 20) or twice daily (n = 20) dose of 1200 mg in patients with previously treated, KRAS G12D–mutant pancreatic ductal adenocarcinoma. Findings from the phase 1/1b RMC-9805-001 study (NCT06040541) examining the drug were presented during the 2024 EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics.

FDA Delays PDUFA Date for Sotorasib Plus Panitumumab in KRAS G12C+ mCRC

The Prescription Drug User Fee Act target action date for the application seeking approval of sotorasib (Lumakras) paired with panitumumab (Vectibix) in the treatment of patients with metastatic colorectal cancer harboring KRAS G12C mutations has been extended from October 17, 2024, to January 17, 2025. This decision will allow for the FDA to review recently submitted supplemental data. Findings from the phase 3 CodeBreaK 300 trial (NCT05198934) showed that at a median follow-up of 7.8 months (range, 0.1-13.9), those who received 960 mg of sotorasib plus panitumumab (n = 53) experienced a median progression-free survival of 5.6 months (95% CI, 4.2-6.3) vs 2.2 months (95% CI, 1.9-3.9) with investigator’s choice of therapy (n = 54; HR, 0.49; 95% CI, 0.30-0.80; P = .006).

NCCN Guideline Update Recommends Adjuvant Ribociclib Plus AI in HR+/HER2– Early Breast Cancer

On October 15, 2024, the National Comprehensive Cancer Network released its Clinical Practice Guidelines in Oncology for breast cancer, recommending ribociclib (Kisqali) plus an aromatase inhibitor as a Category 1 preferred CDK4/6 inhibitor–based regimen in the adjuvant setting for patients with hormone receptor–positive/HER2-negative early breast cancer. The FDA approved adjuvant ribociclib plus an AI for this population in September 2024, and a month later, the European Medicines Agency’s Committee for Medicinal Products for Human Use issued a positive opinion for this indication in this population.

The Top News From ESMO 2024: A Variety of Data Inform Solid Tumor Landscapes

The 2024 ESMO Congress not only provided a forum for the presentation of positive, practice-changing data but also for negative trial data that are equally poised to inform care in the realm of solid tumors. In this exclusive roundup, 23 physicians highlight the most notable trials from the meeting, with the phase 3 MULTISARC (NCT03784014), NIAGARA (NCT03732677), CheckMate 067 (NCT01844505), ENGOT-cx11/GOG-3047/KEYNOTE-A18 (NCT04221945), and KEYNOTE-522 (NCT03036488) trials getting multiple nods from those treating patients with sarcoma; melanoma; and cancers of the cervix, breast, and bladder.