Also known as: American Society for Clinical Oncology, ASCO
BioNTech faces mixed analyst views as Bernstein initiates with a cautious Market Perform rating, while the company secures FDA Fast Track designation for BNT113 and prepares for a shareholder vote on capital restructuring and leadership transition.
The FDA has accepted the New Drug Application for giredestrant plus everolimus in ESR1-mutated, ER-positive, HER2-negative advanced breast cancer. The filing is based on Phase III evERA data showing reduced risk of disease progression or death versus standard-of-care endocrine therapy plus everolimus.
Topline phase 3 VIKTORIA-1 results showed gedatolisib combinations improved progression-free survival versus alpelisib plus fulvestrant in PIK3CA-mutant HR-positive/HER2-negative advanced breast cancer. Celcuity plans a supplemental FDA filing based on the data.
FDA has accepted the NDA for vepdegestrant (ARV-471), an oral PROTAC ER degrader from Arvinas and Pfizer, for ESR1-mutated ER+/HER2- advanced breast cancer. A PDUFA date of June 5, 2026 has been set. The submission is based on positive Phase 3 VERITAC-2 data.
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.
Immunome submitted an NDA to the FDA for varegacestat in desmoid tumors after the Phase 3 RINGSIDE trial showed an 84% reduction in progression risk (HR=0.16) and a 56% objective response rate. The company plans to file in Q2 2026.
A study in stage 3 dMMR colon cancer found that atezolizumab plus chemotherapy after surgery cut recurrence and death risk by 50%. The trial enrolled 712 patients and the regimen is now included in treatment guidelines.
AstraZeneca will report pivotal first-half data on sonesitatug vedotin in Claudin18.2 gastric cancer. The phase 3 Clarity-Gastric01 study is enrolling patients with ≥25% expression.
Ascentage Pharma said six clinical abstracts were selected for ASCO 2026 and four preclinical studies will be presented at AACR 2026. The presentations feature olverembatinib and other pipeline candidates.
Vir Biotechnology has dosed the first patient in a Phase I VIR-5500 expansion cohort for metastatic prostate cancer. The trial is evaluating VIR-5500 as monotherapy and in combination settings across mCRPC and mHSPC.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT06964009 |
DT2216 + Paclitaxel in Platinum-Resistant Ovarian Cancer |
RECRUITING | PHASE1 |
| NCT06907797 |
Tools for Reducing Inequity in Acute Leukemia (TRIAL): Beta Testing |
RECRUITING | NA |
| NCT06895473 |
Intrathecal Cytarabine, Methotrexate, and Hydrocortisone for the Prevention of High-Grade Chimeric Antigen Receptor T-Cell-Associated Neurotoxicity Syndrome |
RECRUITING | PHASE2 |
| NCT06795139 |
Pilot of a Trial Enrollment Diversity Dashboard |
ACTIVE_NOT_RECRUITING | NA |
| NCT06582849 |
Enhanced Assistance During Radiotherapy for Unmet Essential Needs |
COMPLETED | NA |
| NCT06557512 |
Adjuvant Hypofractionated Stereotactic Radiosurgery for Intermediate-risk Meningioma |
RECRUITING | NA |
| NCT06469307 |
Driving Inclusivity, Validity, and Equity in Research Through Strategic Engagement (DIVERSE) |
RECRUITING | NA |
| NCT06377852 |
The CDK4/6 Inhibitor Dosing Knowledge (CDK) Study |
RECRUITING | PHASE3 |
| NCT06089083 |
PROmOting Gynecologic Cancer Patients With Frailty to Achieve Functional Recovery |
RECRUITING | |
| NCT06046014 |
Feasibility of Expressive Writing for Body Image Distress and Anxiety Among Adolescent and Young Adult Cancer Survivors |
COMPLETED | NA |
