Precision Medicine in Oncology®

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.

The FDA has granted fast track designation to ABM-1310 for the treatment of patients with glioblastoma harboring BRAF V600E mutations.

The Committee for Medicinal Products for Human Use has recommended the approval of quizartinib in the European Union for use in combination with standard cytarabine and anthracycline induction and cytarabine consolidation chemotherapy, followed by maintenance quizartinib, for adult patients with newly diagnosed, FLT3-ITD–positive acute myeloid leukemia.

Marina Sharifi, MD, PhD, discusses the benefit of utilizing personalized and targeted therapy approaches in the treatment of patients with breast cancer.

John Seymour, MBBS, FRACP, PhD, discusses the importance of targeted therapy in patients with chronic lymphocytic leukemia.

The integration of novel mRNA biomarkers into the ColoAlert® screening test resulted in high sensitivity and specificity for colorectal cancer.

In this third episode of OncChats: Leveraging Endoscopic Ultrasound in Pancreatic Cancer, Toufic A. Kachaamy, MD, Madappa Kundranda, MD, PhD, and Tamas A. Gonda, MD, share how they would best utilize genetic testing results obtained from endoscopic ultrasound–guided biopsies in pancreatic ductal adenocarcinomas.

Bryan Schneider, MD, discusses agents available for use in the targeting of MET exon 14 mutations in non–small cell lung cancer.

Current research suggests that circulating tumor DNA may have prognostic value when conducted at the conclusion of treatment in large B-cell lymphoma, indicating that minimal residual disease detection using ctDNA assessments such as PhaseEd-Seq could address imitations associated with the use of computed tomography or positron emission tomography/CT scans at this stage.

Early cytogenetic and molecular responses achieved with ponatinib was significantly linked with better long-term progression-free survival and overall survival in patients with highly resistant, pretreated chronic-phase chronic myeloid leukemia.

Lyudmila A. Bazhenova, MD, discusses how to treat patients with non–small cell lung cancer who present with EGFR mutations, highlights how to accurately pinpoint gaps in lung cancer care, and expands on how to address these gaps in patients with non–small cell lung cancer.

Natalie Vokes, MD, discusses emerging biomarkers in non–small cell lung cancer, specifically highlighting the promise of HER3-targeted therapy.

In this second episode of OncChats: Leveraging Endoscopic Ultrasound in Pancreatic Cancer, Toufic A. Kachaamy, MD, Madappa Kundranda, MD, PhD, and Tamas A. Gonda, MD, discuss the techniques used such as endoscopic ultrasound–guided biopsies to collect adequate tissue to perform genomic analyses in pancreatic cancer, and the likelihood for finding actionable mutations in this population.

Treatment with the KRAS G12C inhibitor divarasib (formerly GDC-6036) led to durable responses with a tolerable safety profile in patients with a variety of solid tumors harboring a KRAS G12C mutation.

Sanjay Goel, MD, MS, discusses the safety profile of the TKI tinengotinib as a monotherapy and in combination with chemotherapy in patients with solid tumors.

Corey J. Langer, MD, outlines the prevalence of BRAF mutations in NSCLC and looked ahead to where the development pipeline of agents for the treatment of patients with BRAF-mutated NSCLC is headed.

Sanjay Goel, MD, MS, discusses the mechanism of action of tinengotinib and the efficacy of this agent in patients with cholangiocarcinoma.

The Center for Drug Evaluation, of the National Medical Products Administration in China, has granted breakthrough therapy designation to repotrectinib for use in patients with advanced solid tumors harboring a NTRK gene fusion who experienced disease progression after TKI treatment.

The Center for Drug Evaluation, of the National Medical Products Administration in China, has granted a breakthrough therapy designation to savolitinib for use in patients with locally advanced or metastatic gastric cancer or gastroesophageal junction with MET amplification in whom at least 2 lines of standard therapy have failed.

A supplemental new drug application seeking the full approval of erdafitinib for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma harboring susceptible FGFR3 alterations who progressed during or following at least 1 line of a PD-1/PD-L1 inhibitor in the locally advanced or metastatic setting or within 12 months of neoadjuvant or adjuvant therapy, has been submitted to the FDA.

In this first episode of OncChats: Leveraging Endoscopic Ultrasound in Pancreatic Cancer, Toufic A. Kachaamy, MD, Madappa Kundranda, MD, PhD, and Tamas A. Gonda, MD, discuss how endoscopic ultrasound has changed the diagnosis of pancreatic cancer and how it may also be utilized to guide personalized treatment in nonmetastatic adenocarcinomas.

The FDA has granted fast track designation to ALE.C04 for use as a potential therapeutic option in patients with recurrent or metastatic, Claudin-1–positive head and neck squamous cell carcinomas.

Treatment with erdafitinib resulted in clinical benefit for patients with advanced solid tumors harboring susceptible FGFR alterations who had exhausted all other treatment options, meeting the primary end point of overall response rate of the phase 2 RAGNAR trial.

Japan’s Ministry of Health, Labour, and Welfare has approved fam-trastuzumab deruxtecan-nxki for use in adult patients with unresectable advanced or recurrent, HER2-mutant non–small cell lung cancer that has progressed following chemotherapy.

Selpercatinib demonstrated a statistically significant improvement in progression-free survival vs physician’s choice of cabozantinib or vandetanib in patients with advanced or metastatic RET-mutant medullary thyroid cancer, meeting the primary end point of the phase 3 LIBRETTO-531 trial.

Praful K. Ravi, MB, BChir, MRCP, discusses the use of prostate-specific membrane antigen-targeted therapies in metastatic castration-resistant prostate cancer, highlighting the use of the targeted radioligand lutetium Lu 177 vipivotide tetraxetan.

Zeynep Eroglu, MD, explains the rationale for adding navitoclax to dabrafenib plus trametinib in the treatment of patients with BRAF V600–mutant metastatic melanoma, highlights the methodologies and results of the CTEP-P9466 trial, and describes the implications of this research for this patient population.

The FDA has granted priority review to the supplemental new drug application seeking the approval of ivosidenib for the treatment of patients with IDH1-mutated, relapsed/refractory myelodysplastic syndrome.

The FDA has approved FoundationOne CDx to be utilized as a companion diagnostic for the dual-action tablet of niraparib plus abiraterone acetate, which was approved for use in combination with prednisone in adult patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer.