Memorial Sloan Kettering Cancer Center

GI Innovation dosed the first patient in a phase 1 trial of GI-102, an immune-oncology drug in SC formulation, marking the first Korean firm to do so. The SC formulation aims to enhance efficacy over IV administration and is expected to improve ease of administration and therapeutic outcomes for melanoma. The trial is conducted at 14 institutions in Korea and the U.S., with Samsung Biologics handling GMP production. The phase 1 trial is expected to conclude by February 2025.

A 52-year-old woman with grade 3 invasive ductal carcinoma underwent left mastectomy. Ribociclib's safety profile in NATALEE trial shows neutropenia as the most common toxicity, with 62% all-grade and 42% grade 3. Dose reduction maintains efficacy, with 20% discontinuation rates. Liver-related AEs resolve over time for some patients. Ribociclib and abemaciclib offer options based on safety profiles and patient comorbidities, with ribociclib for 3 years and abemaciclib for 2. Dose reductions are common, maintaining efficacy. Older patients may require lower starting doses due to higher toxicity risks.

Dostarlimab, a PD-1-blocking antibody, received FDA Breakthrough Therapy Designation for locally advanced dMMR/MSI-H rectal cancer, based on a 100% clinical complete response rate. It eradicates tumors without surgery, radiation, or chemotherapy, offering a life-changing immunotherapy for patients.

The FDA granted Jemperli (dostarlimab-gxly) a breakthrough therapy designation for locally advanced dMMR/MSI-H rectal cancer, marking its second designation for this population. Jemperli showed a 100% clinical complete response rate in a phase 2 trial, supporting its potential to improve treatment for patients with this condition.

Dr. Doug Flora, Executive Medical Director of Oncology Services at St. Elizabeth Cancer Center, discusses the growth of the program, attracting top providers, CMS 5-star rating, unique blend of local talent and renowned specialists, clinical trials, personalized medicine, nurse navigation, and whole-person care.

FDA grants breakthrough therapy designation to dostarlimab-gxly (Jemperli) for locally advanced dMMR/MSI-H rectal cancer, based on a 100% clinical complete response rate in a phase 2 study. The treatment showed sustained cCR and a favorable safety profile, with no grade 3 or higher AEs. The AZUR-1 trial continues to evaluate dostarlimab in this patient population.

Researchers at Icahn School of Medicine identified lurbinectedin's mechanism, activating STING-IFN signaling to boost immune response against small-cell lung cancer, enhancing PD-L1 blockade therapy efficacy.

Imlunestrant significantly improved survival in ESR1-mutated ER-positive, HER2-negative advanced breast cancer, outperforming standard therapy in the Phase III EMBER-3 trial. The combination with Verzenio (abemaciclib) also showed improved progression-free survival (PFS) compared to monotherapy. Imlunestrant, an oral selective ER degrader, offers a new all-oral targeted therapy option post-endocrine therapy progression.

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.

Taletrectinib, a next-gen ROS1 TKI, shows superior efficacy, CNS penetration, and safety in ROS1+ NSCLC, with TRUST-I trial data revealing 90.6% ORR in TKI-naive patients and 51.5% in crizotinib-pretreated. TRUST-II global trial supports consistent activity and safety, with pooled analysis confirming taletrectinib's benefit as a first-line option.