Sensei Biotherapeutics dosed the first patient in a Phase 1b/2 trial of PIKTOR (sapanisertib + serabelisib) in HR+/HER2- advanced breast cancer. The multi-node PI3K/AKT/mTOR inhibitor previously showed a 47% overall response rate in a Phase 1b trial.
The FDA approved Keytruda and Keytruda Qlex with paclitaxel, with or without bevacizumab, for PD-L1-positive platinum-resistant ovarian-related cancers. The Phase III KEYNOTE-B96 trial showed improved progression-free and overall survival versus placebo.
Merck received FDA approval in early February 2026 for KEYTRUDA and KEYTRUDA QLEX in PD-L1-positive platinum-resistant ovarian cancer. The decision marks the first approval of a PD-1 inhibitor regimen for this setting.
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.
The FDA granted fast track designation to SIM0505, a CDH6-targeting antibody-drug conjugate, for platinum-resistant ovarian cancer based on preclinical and early clinical data. A phase 1 trial is currently evaluating the drug in advanced solid tumors, with initial data expected at the 2026 ASCO conference. The company plans to begin dose optimization studies in ovarian cancer patients in Q2 2026.
The FDA has approved Lifyorli (relacorilant) plus nab-paclitaxel for platinum-resistant ovarian cancer based on trial data showing improved survival. Separately, the agency granted Breakthrough Therapy designation to Lilly's sofetabart mipitecan for the same condition, expediting development of the antibody-drug conjugate.
Pembrolizumab-based regimens demonstrated significant survival improvements in two separate trials: KEYNOTE-B15 for muscle-invasive bladder cancer and KEYNOTE-B96 for platinum-resistant ovarian cancer, with FDA approval granted for the ovarian cancer indication.
FDA approved pembrolizumab with paclitaxel, with or without bevacizumab, for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma with PD-L1 CPS ≥1, based on KEYNOTE-B96 trial results.
AbbVie has successfully transitioned from Humira dependence to growth driven by Skyrizi and Rinvoq, while maintaining a 54-year dividend increase streak and expanding its pipeline to roughly 90 programs through strategic acquisitions.
Final analysis of Merck's Phase 3 KEYNOTE-B96 trial shows KEYTRUDA plus paclitaxel with or without bevacizumab significantly improved overall survival in platinum-resistant recurrent ovarian cancer patients, reducing death risk by 18%.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07604766 |
An Extension Study to Assess the Efficacy of Rina-S Compared to Treatment of Investigator's Choice in Participants With Platinum Resistant Ovarian Cancer in China |
NOT_YET_RECRUITING | PHASE3 |
| NCT07489287 |
GB-5267 for the Treatment Platinum-Resistant Ovarian, Peritoneal, or Fallopian Tube Cancer |
NOT_YET_RECRUITING | PHASE1 |
| NCT07226427 |
A First-in-Human Study of MEN2501 in Participants With Platinum-Resistant Ovarian Cancer |
RECRUITING | PHASE1 |
| NCT07109414 |
Trial of NP-G2-044 (Prilukae) Combined With PLD for Treatment of Platinum-Resistant Ovarian Cancer (ULTIMUS-1) |
ACTIVE_NOT_RECRUITING | PHASE2/PHASE3 |
| NCT06730347 |
A Study of Lorigerlimab in Participants With Advanced Solid Tumors |
RECRUITING | PHASE2 |
| NCT06710288 |
A Phase 2, Open-label, Single-arm Study Of Autologous M-CENK Adoptive Cell Therapy And N-803 (IL-15 Superagonist) In Combination With Gemcitabine In Participants With Recurrent Platinum-Resistant High-Grade Ovarian Cancer |
RECRUITING | PHASE2 |
| NCT06619236 |
Study to Assess the Efficacy of Rina-S Compared to Treatment of Investigator's Choice in Participants With Platinum Resistant Ovarian Cancer |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT06586957 |
A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors |
RECRUITING | PHASE1 |
| NCT06547840 |
A Study of MOv18 IgE in Patients With Solid Tumours That Express Folate Receptor Alpha |
RECRUITING | PHASE1 |
| NCT06515613 |
A Phase 1 Study of CTIM-76 in Patients With Recurring Ovarian Cancer and Other Advanced Solid Tumors |
RECRUITING | PHASE1 |
