Precision Medicine in Oncology®

The China National Medical Products Administration’s Center for Drug Evaluation granted 2 breakthrough therapy designations to repotrectinib for the treatment of patients with ROS1-positive metastatic non–small cell lung cancer.

Sotorasib demonstrated clinically meaningful activity and acceptable tolerability in heavily pretreated patients with KRAS G12C–mutated advanced pancreatic cancer, according to date from the single-arm, phase 1/2 CodeBreak 100 trial.

The addition of quizartinib to standard induction and consolidation chemotherapy and then continued as a single agent doubled median overall survival vs standard chemotherapy alone in patients with newly diagnosed FLT3-ITD–positive acute myeloid leukemia.

B7-H3, a member of the same protein family as PD-L1, has garnered attention as one of a slew of alternative targets riding the wave of success of immune checkpoint inhibitors in cancer immunotherapy.

The FDA has given the green light to FoundationOne CDx to identify patients with ROS1 fusion–positive non–small cell lung cancer or NTRK fusion–positive cancers who might be candidates for entrectinib.

A combination comprised of cobimetinib and vemurafenib demonstrated evidence of antitumor activity in patents with advanced solid tumors harboring BRAF V600E and other mutations who are not otherwise eligible to receive other FDA-approved therapies.

Seribantumab was found to produce encouraging overall response rates with acceptable tolerability when used as a monotherapy in patients with solid tumors harboring NRG1 fusions.

Pediatric patients with non–central nervous system, TRK fusion–positive cancers who were enrolled to the phase 1/2 SCOUT and phase 2 NAVIGATE trials and received larotrectinib continued to experience rapid and durable tumor-agnostic efficacy and prolonged survival.

Alpelisib plus fulvestrant demonstrated a clinical benefit regardless of gene mutation status in patients with hormone receptor–positive, HER2-negative advanced breast cancer, including those with FGFR1 or FGFR2 alterations.

Second-line treatment with pemigatinib may be linked with prolonged progression-free survival compared with other systemic therapies in patients with cholangiocarcinoma harboring FGFR2 fusions or rearrangements.

The addition of sorafenib to conventional chemotherapy was safe and demonstrated evidence of improved outcomes in pediatric patients with FLT3-ITD–positive acute myeloid leukemia.

The FDA has approved ivosidenib (Tibsovo) in combination with azacitidine for the treatment of patients with newly diagnosed IDH1-mutated acute myeloid leukemia who are aged 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.

The FDA has granted a fast track designation to seribantumab for the tumor-agnostic treatment of advanced solid tumors that harbor NRG1 gene fusions.

Rebecca A. Previs, MD, discusses the role of biomarkers in uterine and endometrial cancers, the standard of care for patients with different biomarkers in uterine cancer, how PARP inhibitors have affected the treatment of ovarian cancer, and the key clinical trials in gynecologic cancers.

The prevalence of ESR1 mutations in endocrine-resistant metastatic breast cancer has paved an avenue for investigators to explore their role in the promotion of metastasis.

Kelvin P. Lee, MD, discusses the importance of collaboration in precision medicine.

A marketing authorization application has been submitted to the European Medicines Agency seeking the approval of adagrasib for therapeutic use in previously treated patients with non–small cell lung cancer harboring a KRAS G12C mutation.

Maher Albitar, MD, and Andre H. Goy, MD, discuss case studies in diffuse large B-cell lymphoma.

Maher Albitar, MD, and Andre H. Goy, MD, discuss the importance of testing for molecular abnormalities in acute myeloid leukemia.

Maher Albitar, MD, and Andre H. Goy, MD, share insights regarding molecular complexities in mantle cell lymphoma.

Following in the footsteps of the cytokine interleukin-2, IL-15 affords investigators similar qualities as a target without the associated toxicities of its immunotherapeutic predecessor.

Virginia G. Kaklamani, MD, discussed the emerging role of PARP inhibitors, practice-changing updates in HER2-positive breast cancer, the utilization of CDK4/6 inhibitors in hormone receptor–positive, HER2-negative breast cancer, and the various therapeutic classes and their effects on care in triple-negative breast cancer.

The FDA has granted a fast track designation to the myeloid kinome inhibitor, HM43239, for use as a potential therapeutic option in patients with relapsed or refractory acute myeloid leukemia whose tumors harbor a FLT3 mutation.

Christos Vaklavas, MD, discusses the increasing emphasis on investigating tumor biology in breast cancer, plus the evolving treatment landscapes in HER2-positive breast cancer, hormone receptor–positive, HER2-negative breast cancer, and triple-negative breast cancer.

Novel strategies to modulate the microbiota are now an area of robust investigation

Jun Zhang, MD, PhD, discusses key clinical trials utilizing immunotherapy in non–small cell lung cancer, the continued importance of biomarker testing to help inform treatment decisions, and targeted therapies for EGFR, MET, and ALK mutations.

Kelvin P. Lee, MD, discusses the importance of sequencing in precision medicine.

Lynette M. Sholl, MD, discusses why cancer pathologists still want better tissue samples.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended granting marketing authorization to capmatinib for use as a single agent in select adult patients with advanced non–small cell lung cancer harboring a METex14 skipping alteration.

The safety, tolerability, and preliminary efficacy of the irreversible, small molecule pan-FGFR inhibitor KIN-3248 is under investigation in adult patients with advanced tumors harboring FGFR2 and/or FGFR3 gene alterations, as part of the phase 1 KN-4802 trial.