Precision Medicine in Oncology®

China’s National Medical Products Administration has granted conditional marketing approval to vebreltinib for the treatment of patients with non–small cell lung cancer harboring MET exon 14 skipping mutations.

The FDA has approved repotrectinib (Augtyro) for the treatment of adult patients with locally advanced or metastatic ROS1-positive non–small cell lung cancer.

In this second episode of OncChats: Assessing the Promise of AI in Oncology, Toufic A. Kachaamy, MD, and Douglas Flora, MD, LSSBB, FACCC, explain how artificial intelligence tools may be leveraged in the oncology field to provide personalized care.

The European Medicines Agency had validated a marketing authorization application seeking the approval of the combination of encorafenib and binimetinib for the treatment of adult patients with BRAF V600–mutant advanced non–small cell lung cancer.

Sarah Goldberg, MD, MPH, highlights the mechanism of action of VIC-1911, expands on its ongoing investigation in the phase 1 trial, and sheds light on next steps planned for the agent’s investigation in KRAS G12C–mutant non–small cell lung cancer.

In this first episode of OncChats: Assessing the Promise of AI in Oncology, Toufic A. Kachaamy, MD, and Douglas Flora, MD, LSSBB, FACCC, define artificial intelligence and highlight the goals of these tools in healthcare.

Julia Rotow, MD, discusses results from a first-in-human phase 1 study of the EGFR-targeting, BCL-XL–inhibiting antibody-drug conjugate ABBV-637 in combination with osimertinib in patients with relapsed/refractory, EGFR-mutated non–small cell lung cancer.

Despite the discovery of protein arginine methyltransferase 5 more than 20 years ago, interest in the potential oncogene as a treatment target for patients with hematologic and solid malignancies has increased in recent years with the advancement of multiple novel agents through preclinical and early-phase studies.

Datopotamab deruxtecan elicited encouraging responses in patients with heavily pretreated non–small cell lung cancer harboring actionable genomic alterations.

Courtney D. DiNardo, MD, MSCE, discusses the significance of the FDA approval of ivosidenib in patients with relapsed/refractory, IDH1-mutated myelodysplastic syndromes.

Treatment with combinations using sotorasib at multiple dose levels and panitumumab led to improved progression-free survival vs standard of care in patients with chemorefractory metastatic colorectal cancer harboring KRAS G12C mutations.

Fam-trastuzumab deruxtecan-nxki elicited responses that proved to be durable in patients with a range of solid tumors harboring HER2 mutations.

The combination of amivantamab-vmjw (Rybrevant) and chemotherapy produced a median progression-free survival of 11.4 months vs 6.7 months with chemotherapy alone in patients with advanced, EGFR exon 20 insertion–positive non–small cell lung cancer.

Selpercatinib (Retevmo) showcased superior efficacy, with improved progression-free survival, vs chemotherapy with or without pembrolizumab in the first-line treatment of patients with RET fusion–positive non–small cell lung cancer.

The FDA has granted accelerated approval to entrectinib (Rozlytrek) for pediatric patients aged older than 1 month with solid tumors that harbor a NTRK gene fusion without a known acquired resistance mutation, are metastatic, or where surgical resection is likely to result in severe morbidity, and have progressed after treatment or have no satisfactory standard therapy options.

David S. Hong, MD, and David Sommerhalder, MD, discuss the unmet needs for patients with KRAS G12C–mutant non–small cell lung cancer (NSCLC) and colorectal cancer (CRC) that prompted the initiation of the RMC-6291-001 trial; the key efficacy and safety findings with RMC-6291 in patients with NSCLC and CRC; and potential next steps for this agent.

Wade T. Iams, MD, discusses the impact of adagrasib on the treatment of patients with KRAS G12C-mutant NSCLC in the second line, as well as its integration into clinical practice.

Expression of DLL3, an inhibitor ligand of the Notch pathway associated with tumorigenesis, has emerged as a target of interest for drug development.

Omar Abughanimeh, MD, discusses the evolution of targeted therapies for patients with EGFR-positive non-small cell lung cancer.

Lirafugratinib demonstrated clinical activity in multiple subsets of patients with FGFR2-altered solid tumors, including those with FGFR2-altered hormone receptor–positive, HER2-negative breast cancer.

The FDA has approved FoundationOne® CDx and FoundationOne Liquid CDx for use as companion diagnostics to identify patients with metastatic non–small cell lung cancer harboring BRAF V600E mutations who may benefit from treatment with the combination of encorafenib plus binimetinib.

Wade T. Iams, MD, discusses the impact of the phase 3 FLAURA2 trial in patients with EGFR-mutant non–small cell lung cancer, highlighting the notable improvements in progression-free survival that the approach elicits.

The FDA has approved encorafenib (Braftovi) plus binimetinib (Mektovi) for adult patients with metastatic non–small cell lung cancer harboring a BRAF V600E mutation, as detected by an FDA-approved test.

The FDA has approved FoundationOne CDx for use as a companion diagnostic for selpercatinib, which was approved by the FDA for the treatment of adult patients with locally advanced or metastatic solid tumors harboring a RET gene fusion whose disease has progressed on or following prior systemic treatment, or who have no satisfactory alternative treatment options.

The FDA has granted de novo marketing authorization for the Invitae Common Hereditary Cancers Panel, an in vitro diagnostic test designed to detect genetic variants associated with an elevated risk of developing certain types of cancer.

Treatment with the first-in-class menin inhibitor revumenib generated complete remissions or complete remissions with partial hematological recovery in adult and pediatric patients with relapsed/refractory acute myeloid leukemia or acute lymphoblastic leukemia harboring KMT2A rearrangements.

Jeremy C. Jones, MD, discusses the applications of circulating tumor DNA testing in colorectal cancer.

Treatment with the combination of sotorasib carboplatin, and pemetrexed produced responses and demonstrated safety in patients with KRAS G12C–mutated, advanced non–small cell lung cancer, according to data from the phase 1/2 CodeBreaK 101 trial.

The FDA has granted fast track designation to IDE161 for use in adult patients with advanced or metastatic hormone receptor–positive, HER2-negative breast cancer harboring BRCA1/2 mutations who have progressed after at least 1 hormonal therapy, a CDK4/6 inhibitor, and a PARP inhibitor.

The phase 3 ENHANCE-2 trial examining the frontline combination of magrolimab and azacitidine vs physician’s choice of venetoclax with azacitidine or intensive chemotherapy in patients with acute myeloid leukemia and TP53 mutations has been discontinued, according to an announcement from Gilead Sciences.