The FDA approved Novocure’s Optune Pax, a wearable tumor-treating fields device, for pancreatic cancer in combination with chemotherapy. Phase III PANOVA-3 data showed delayed pain progression and improved one-year overall survival in inoperable locally advanced disease.
ImmunityBio said the Saudi FDA encouraged submission of a regulatory package for recombinant BCG and opened talks on expanding ANKTIVA with checkpoint inhibitors to additional tumor types. The company expects to file the rBCG package within weeks.
Sino Biopharmaceutical won Chinese approval for a new indication for benmelstobart as maintenance therapy in unresectable stage III NSCLC after chemoradiotherapy. Phase III R-ALPS data showed significantly prolonged progression-free survival versus placebo and a manageable safety profile.
Neoadjuvant chemoimmunotherapy showed a 51.5% pathological complete response rate in 127 patients with resectable squamous cell lung cancer. Grade 3-4 treatment-related adverse events occurred in 11.8% of patients.
Crescent Biopharma dosed the first patient in its ASCEND Phase 1/2 trial of CR-001, a PD-1 x VEGF bispecific antibody for solid tumors. The company also reported Q1 2026 results and outlined pipeline milestones including ADC combination trials expected in the second half of 2026.
EMA has initiated a rolling review of OS Therapies' OST-HER2 for preventing recurrence in fully resected pulmonary metastatic osteosarcoma. A potential conditional marketing authorization decision is expected in Q4 2026, with a confirmatory Phase 3 trial planned for Q3 2026 in Australia.
Incyte has started the phase 3 Dawn-03 trial of INCB161734 plus chemotherapy in first-line KRAS G12D-mutant pancreatic cancer. The move comes while the phase 1 study remains halted in four European countries after pneumonitis cases, including one grade 5 event.
January and March 2026 drug pipeline updates included Phase 3 results, Fast Track designations and Priority Review decisions across multiple disease areas. Mavacamten, teplizumab-mzwv, anifrolumab, AXS-05, gedatolisib and AFTX-201 were among the programs with notable milestones.
Bayer’s sevabertinib has obtained domestic approval as an imported rare drug for HER2-mutant non-small cell lung cancer. The oral reversible HER2-targeted TKI was previously approved by the FDA for previously treated patients.
Updated phase I data showed zoldonrasib produced a 52% confirmed objective response rate and 93% disease control rate in previously treated KRAS G12D-mutant NSCLC. No grade 4 or higher treatment-related adverse events were observed at the recommended phase II dose.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| 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 |
| NCT07579221 |
Ph1/2 Trial Of Navlimetostat With Pumitamig In MTAP-Deficient Advanced Non-Small Cell Lung Cancer |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT07578571 |
A Phase 1 Study of IM-1617 in Participants With Advanced Cancer |
RECRUITING | PHASE1 |
