AMERICAN SOCIETY OF CLINICAL ONCOLOGY

FDA grants breakthrough therapy designation to GSK5764227 for relapsed/refractory extensive-stage small cell lung cancer, aiming to expedite development. GSK plans phase 1/2 trials, citing a 3% five-year survival rate. Encouraging efficacy shown in ARTEMIS-001 trial, with further results expected at the 2024 World Conference on Lung Cancer.

RYBREVANT® plus LAZCLUZE™, approved by the FDA, is the first chemotherapy-free regimen for EGFR-mutated NSCLC, showing a 30% reduced risk of disease progression or death versus osimertinib, with a nine-month longer median duration of response. This marks a significant advancement in NSCLC treatment.

FDA grants priority review to vimseltinib for TGCT treatment, with a PDUFA target of February 17, 2025. Supported by phase 3 MOTION study data, vimseltinib showed a 40% ORR vs 0% placebo, significant clinical improvements, and manageable safety profile.

FDA approves Voranigo (vorasidenib), an IDH1 and IDH2 inhibitor, for treating Grade 2 IDH-mutant glioma in patients 12+ years old post-surgery. Voranigo offers a once-daily pill for disease management, with Phase 3 INDIGO trial results showing significant progression-free survival extension and safety.

Recent advancements in breast cancer treatment, including CDK4/6 inhibitors, have reduced distant recurrence risks. The necessity of chemotherapy before these treatments is questioned, with studies showing modest benefits. However, the absolute benefit of chemotherapy remains uncertain, highlighting the need for further research to determine its clinical significance in the context of newer therapies.

Xspray Pharma received a Complete Response Letter from the FDA for Dasynoc, a CML and ALL treatment, requesting additional info on labeling and manufacturing inspection. No new clinical studies are required, and Xspray aims to address FDA concerns promptly.

Ciltacabtagene autoleucel (cilta-cel) significantly improves overall survival in relapsed, lenalidomide-refractory multiple myeloma patients, as shown in the CARTITUDE-4 study. It reduces disease progression risk by 74% and outperforms standard care in progression-free survival, response rates, and minimal residual disease negativity. Approved by the FDA in 2022 and 2024 for specific patient groups.

SpringWorks Therapeutics completes NDA submission to FDA for mirdametinib, an investigational MEK inhibitor for treating NF1-PN in children and adults. The submission includes data from the Phase 2b ReNeu trial, showing significant response rates, deep and durable responses, and a manageable safety profile. Mirdametinib has received Orphan Drug and Fast Track designations from the FDA and is planned for MAA submission to the EMA in the second half of 2024.

Verastem Oncology announced interim results from the RAMP 205 trial for metastatic pancreatic cancer, showing an 83% ORR in one cohort. They're also submitting an NDA for a KRAS mutant ovarian cancer treatment and collaborating on NSCLC trials. VSTM stock dropped 59% premarket Friday.

Johnson & Johnson's cilta-cel shows promise in treating multiple myeloma, with a 73% risk reduction in disease progression or death in early relapse patients. Data from the CARTITUDE-4 study, presented at ASCO 2024, highlights its efficacy over standard treatments, especially in high-risk subgroups, indicating potential for broader application.