U.S. Food and Drug Administration Approves FoundationOne®CDx as a Companion Diagnostic for TEPMETKO® (tepotinib) to Identify Patients with MET Exon 14 Skipping Alterations in Non-Small Cell Lung Cancer
“BOSTON, May 21, 2026 – Foundation Medicine, Inc., a global, patient-focused precision medicine company, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®CDx to be used as a companion diagnostic (CDx) for TEPMETKO® (tepotinib) developed by EMD Serono, the healthcare business of Merck KGaA, Darmstadt, Germany in the U.S. and Canada.”
Global Development Accelerates Further: Henlius’ PD-L1 ADC HLX43 Completes First Patient Dosing in EU for Phase 2 MRCT
“Shanghai, China, May 21, 2026 — Shanghai Henlius Biotech, Inc. (2696.HK) today announced that the first patient in the European Union (EU) has been successfully dosed in Spain in the international multi-center Phase 2 clinical trial (HLX43-NSCLC201) evaluating HLX43, an innovative programmed death-ligand 1 (PD-L1) targeting antibody-drug conjugate (ADC), for the treatment of advanced non-small cell lung cancer (NSCLC).”
Negative Non-Resection Biopsy After Positive LDCT Screening Linked to Lung Cancer Risk
“Key Point: The 10-year incidence of lung cancer was 24.1% in the non-resection biopsy group and 10.7% in the resection biopsy group.”
Taletrectinib and Brain Metastases in Non–Small Cell Lung Cancer
“Brain metastases are a growing concern in patients with non–small cell lung cancer (NSCLC). As treatment advances allow patients to live longer, the likelihood of developing brain metastases increases—a reflection of the disease’s natural progression over time. Managing these metastases early on is feasible, but the addition of brain radiation carries real costs and risks.”
Histological transformation in lung cancer: a single-arm meta-analysis and systematic review
“Conclusions: Histological transformation occurs in a clinically relevant proportion of EGFR-TKI–resistant EGFR-mutant lung cancer, and is associated with poor post-transformation outcomes.”
Cancer center lung experts help create new national guidelines for safe CT lung cancer screening
“A leading group of 25 medical experts from across the country, including two at UC Davis Comprehensive Cancer Center, has released new guidelines designed to improve care for patients undergoing low-dose CT (computed tomography) lung cancer screening.”
Checkpoint Inhibitors in Lung Cancer: When One Drug Isn’t Enough
“Understanding how T cells recognize and attack tumors is fundamental to grasping why checkpoint inhibitors work—and why they sometimes don’t. During a Case-Based Roundtable event in Cleveland, Ohio, Neal Ready, MD, Duke Cancer Center, discussed this and the implications for the treatment of patients with non–small cell lung cancer (NSCLC).”
Mayo Clinic in Florida advances lung cancer care with single-port robotic surgery
“Guided by the principle that “the needs of the patient come first,” Mayo Clinic thoracic surgeons have begun using a single-port robotic system for surgeries that was recently cleared by the Food and Drug Administration (FDA). This minimally invasive approach enables surgeons to operate with enhanced precision and builds upon Mayo Clinic’s leadership in advancing lung cancer care.”
FDA Backs Protocol Changes for LP-300 Trial in Non–Small Cell Lung Cancer
“Key Takeaways: Protocol revisions narrow eligibility to EGFR exon 21 L858R after TKI progression and convert HARMONIC from randomized to single-arm due to control-arm feasibility in a niche, pretreated population. L858R constitutes ~40% of EGFR-mutant NSCLC globally and up to 50% in Asian patients, and is associated with poorer outcomes on osimertinib versus exon 19 deletions.”
Fibroblast-derived HSD11B1 deficiency drives lung cancer in never-smokers through steroid metabolic imbalance
“These findings identify fibroblast-derived HSD11B1 as a gatekeeper of metabolic balance in the lung, with its loss linked to early disease progression and poorer outcomes in patients. By uncovering a metabolic mechanism that is distinct from smoking-related pathways, this work provides fresh insight into why never-smokers develop lung cancer and suggests potential new avenues for prevention and treatment.”
Hafnium Oxide Nanoparticles Show Feasibility in Stage 3 Lung Cancer
“Key Takeaways: Intratumoral/intranodal NBTXR3 injection met protocol feasibility criteria and was performed safely in thoracic lesions and involved nodes. No serious TEAEs emerged, and neither cCRT delivery nor transition to consolidation durvalumab was delayed or compromised.”
Durvalumab plus anlotinib versus durvalumab alone as maintenance treatment in extensive-stage small-cell lung cancer (DURABLE): a multicenter, randomized, phase II trial and biomarker analysis
“Patients with impaired antigen presenting capacity or low bTMB tended to show improved outcomes with combined maintenance therapy. While similar efficacy between the two groups was observed in patients with high antigen presenting capacity or high bTMB. These findings suggest that durvalumab plus anlotinib might be an effective and well-tolerated maintenance treatment option in ES-SCLC.”
DESTINY-Lung03: T-DXd Confirms Activity in HER2-Overexpressing NSCLC, but Triplet Therapy Falls Short
“DESTINY-Lung03 Part 1 provides an important signal for the treatment of HER2-overexpressing non-small cell lung cancer (NSCLC). The study confirms that trastuzumab deruxtecan (T-DXd) monotherapy has clinically meaningful activity in previously treated metastatic HER2-overexpressing NSCLC, while also showing that combining T-DXd with durvalumab plus platinum chemotherapy created unacceptable toxicity and does not support further development of this triplet strategy in this patient population (Planchard et al.).”
