New clinical data for ANKTIVA immunotherapy in lung cancer, a study on EBV-driven resistance via ADAR1 RNA editing, and research on microbiome metabolites modulating immunotherapy response were presented at major conferences and in recent publications.
Akeso reported overall survival benefit for ivonescimab plus chemotherapy in Phase III lung cancer study. The company enrolled first patient in Phase Ib/II trial of next-generation HER3 ADC AK138D1 for advanced breast cancer. Akeso also received China approval to start Phase II trials for AK139 bispecific antibody.
Multiple recent studies evaluate different immunotherapy approaches for advanced NSCLC, including long-term benefits for nivolumab plus ipilimumab with chemotherapy in PD-L1-negative tumors, limited advantages from PD-(L)1 rechallenge strategies, and early positive signals from combining TIGIT and PD-1 inhibitors in PD-L1-high patients.
Patients with stage 4 lung, sarcoma, and gastro-oesophageal cancer describe their experiences with targeted therapies, chemotherapy, and immunotherapy, highlighting varying outcomes and financial challenges.
The FDA has cleared CStone Pharmaceuticals' investigational new drug application to begin a Phase II trial of its trispecific antibody CS2009 in advanced solid tumors. The multicenter trial will evaluate monotherapy and combination regimens across nine cancer types in Australia, China, and the U.S. Initial Phase I data showed a favorable safety profile and encouraging antitumor activity.
Merck and Gilead discontinued a Phase 3 lung cancer trial due to lack of statistical significance, while Pfizer initiated a new Phase 1 trial and Roivant Sciences completed enrollment in its Phase 2 PHocus trial for pulmonary hypertension.
Key oncology developments include a $315 million partnership between Astellas and Vir for the prostate cancer T-cell engager VIR-5500, with updated phase 1 data showing an 82% PSA50 rate. The FDA accepted a filing for Ono Pharmaceuticals' tirabrutinib seeking accelerated approval in primary central nervous system lymphoma. Research findings also identified a new kidney cancer biomarker and showed promising results for the TRK inhibitor repotrectinib and the breast cancer triple therapy gedatolisib plus palbociclib and fulvestrant.
BioNTech presented phase 2 data for HER2-directed ADC Trastuzumab Pamirtecan showing 47.9% response rate in endometrial cancer, with FDA submission planned for 2026. BioLineRx dosed first patient in phase 1/2a GLIX1 trial for glioblastoma and reported new preclinical data. Both companies presented at ASCO 2026.
Tempus has launched "Preview," an AI-powered tool that provides early cancer insights within one day of sample receipt to inform treatment planning. The tool focuses on high-impact biomarkers including MSI-H, EGFR mutations, and FGFR fusions across several cancer types. The launch aligns with expert emphasis on the critical role of early biomarker testing in personalizing therapy for EGFR-mutated NSCLC.
Three trials show ultra-low-dose checkpoint inhibitors retain efficacy with reduced toxicity and dramatically lower costs. DELII and Patil et al. trials tested low-dose nivolumab in solid tumors and HNSCC; NIVIPIT tested intratumoral low-dose ipilimumab in melanoma.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07613424 |
A Study of MET Concordance and Gene Profiling in 1L NSCLC (Genomet) |
NOT_YET_RECRUITING | NA |
| NCT07608835 |
IMMUNO-LUNG : Identification of Biomarkers and Therapeutic Targets for Pulmonary Immunotherapy |
RECRUITING | NA |
| NCT07603856 |
A Study Evaluating The Combination of Immunotherapy With Radiotherapy in Non-Small Cell Lung Cancer |
NOT_YET_RECRUITING | PHASE2 |
| NCT07601399 |
An EAP Treatment Protocol of Zipalertinib |
AVAILABLE | |
| NCT07599007 |
Repotrectinib Post-Marketing Surveillance in Korean Patients With ROS1-Positive Non-Small Cell Lung Cancer (NSCLC) or Solid Tumors Harboring a Neurotrophic Tyrosine Receptor Kinase (NTRK) Gene Fusion |
NOT_YET_RECRUITING | |
| NCT07594522 |
A Study of Ivonescimab in People With Non-Small Cell Lung Cancer |
RECRUITING | PHASE1/PHASE2 |
| NCT07594067 |
TCR1188-ABC Cells in KRAS-mutated Cancers |
NOT_YET_RECRUITING | PHASE1 |
| NCT07593872 |
XR-Assisted PET/CT Navigation for Cervical Lymph Node Dissection in Lung Cancer |
NOT_YET_RECRUITING | NA |
| NCT07589205 |
Study of IBI3028 in Participants With Locally Advanced, Unresectable, or Metastatic Solid Tumors |
RECRUITING | PHASE1 |
| NCT07586826 |
Romiplostim N01 Plus ATRA for Persistent Isolated Chemotherapy-Induced Thrombocytopenia After Complete Remission of Gynecologic, Breast, or Lung Solid Tumors |
RECRUITING | PHASE2 |
