Vorasidenib

MSKCC advanced cancer treatments in 2024 include new surgical techniques, vaccines, drugs enhancing radiation, and diagnostic tools. The FDA approved 11 drugs based on MSK's pivotal clinical trials, covering new uses for existing drugs, effective drug combinations, engineered cell therapies, and novel targeted therapies. Key developments include a KRAS vaccine for pancreatic and colorectal cancer, combination drug-radiation treatment for basal cell carcinoma, noninvasive E-nose for lung cancer detection, improved transplant success with partially matched donors, exercise impact on prostate cancer biomarkers, new imaging for lung and prostate cancers, TIL therapy for non-small cell lung cancer, robotic neurosurgery for spinal tumors, avoiding surgery for HPV throat cancer with innovative radiation, imlunestrant for ER+, HER2- advanced breast cancer, mRNA vaccine for pancreatic cancer, and immunotherapy for rectal cancer. FDA approvals included tepotinib for METex14 lung cancer, CAR T treatment for mantle cell lymphoma, selpercatinib for RET-linked thyroid cancer, repotrectinib for NTRK fusion cancers, adagrasib with cetuximab for KRAS-G12C colorectal cancer, afamitresgene autoleucel for synovial sarcoma, vorasidenib for IDH glioma, inavolisib with fulvestrant and palbociclib for breast cancer, revumenib for KMT2A leukemia, zanidatamab for HER2 biliary tract cancer, and zenocutuzumab for NRG1 fusion pancreatic and lung cancers.

The IDH market is set to grow rapidly due to expanded indications for approved therapies and increased R&D. Key players like Servier and Bayer are developing novel IDH inhibitors, with IDHIFA (enasidenib) being the first-in-class oral targeted inhibitor for IDH2-mutated AML. IDH inhibitors, including TIBSOVO (ivosidenib) and REZLIDA (enasidenib), are FDA and EMA-approved for various cancers. Vorasidenib, in advanced development, aims to treat IDH-mutant diffuse glioma. The market growth is driven by advancements in research and expanding pipeline of IDH inhibitors.

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Vorasidenib showed significant improvements in progression-free survival (PFS) and tumor shrinkage in patients with IDH1/2-mutated diffuse glioma, with a 65% reduction in disease progression risk compared to placebo, according to the phase 3 INDIGO trial. The study also confirmed better seizure control and a reduction in tumor volume with vorasidenib, with no additional safety concerns observed.

Vorasidenib (Voranigo) and ivosidenib (Tibsovo) showed sustained clinical benefit in IDH1-mutant diffuse glioma patients post-surgery, with 64% and 45.4% experiencing tumor reduction, respectively. Vorasidenib had an overall response rate of 45.5% and a median time to response of 9.2 months, while ivosidenib had a 31.8% response rate and a median time to response of 5.6 months. Both treatments demonstrated durable disease control and favorable safety profiles.

Vorasidenib maintained twice the progression-free survival (PFS) in IDH-mutant low-grade glioma patients post-surgery compared to placebo, with a 65% reduction in the hazard for disease progression or death. Median PFS and time to next intervention (TTNI) were not estimable with vorasidenib versus 11.4 months and 20.1 months for placebo, respectively. Vorasidenib showed robust efficacy, manageable safety, and better seizure control, reducing tumor volume and causing shrinkage.

West China Lecheng Hospital introduces Vorasidenib, a first-in-class IDH dual inhibitor, for IDH-mutant diffuse glioma treatment, marking its first use in Asia before Europe. Vorasidenib, approved in the US and several other countries, aims to improve outcomes for glioma patients with IDH mutations, with a real-world study underway in Boao Lecheng.