FAILED TRIAL: Ph 3 KEYFORM-007 trial of favezelimab + KEYTRUDA did not meet its primary endpoint of OS in patients with previously treated PD-L1+ve MSS mCRC October 1, 2024
FDA Advisory Committee Vote on Benefit-Risk Profile of PD-1 Inhibitors, including TEVIMBRA®, for Treatment of ESCC and Gastric/GEJ Cancers recommends a class-wide PD-L1 expression level cut-off across PD-1 inhibitors October 1, 2024
NDA Resubmitted to FDA for Camrelizumab + Rivoceranib for 1L Unresectable HCC Boosted by CARES-310 Leading OS Analysis October 1, 2024
FRUZAQLA (fruquintinib) approved in Japan for the Treatment of Unresectable Advanced or Recurrent CRC October 1, 2024
European Commission approves VYLOY (zolbetuximab) + chemo combo for 1L HER2-neg, CLDN 18.2 +ve gastric/GEJ adenocarcinoma September 25, 2024
Positive Preliminary Data Reported in Ph 1b/2 Study of Ampligen and Imfinzi as a Combination Therapy for Late-Stage Pancreatic Cancer September 24, 2024
FAILED TRIAL: CONTACT-02 Ph 3 mCRC trial did not meet statistical significance of OS endpoint September 17, 2024
Certepetide Granted FDA Orphan Drug Designation for the Treatment of Cholangiocarcinoma September 10, 2024
GI Innovation Announces New Clinical Trial Collaboration and Supply Agreement to Evaluate GI-102 + KEYTRUDA in Patients with IO-Resistant HCC, Melanoma, and RCC September 3, 2024
Supplemental NDA for fruquintinib + paclitaxel for treatment of 2L advanced gastric or GEJ adenocarcinoma voluntarily withdrawn in China September 3, 2024
FAILED TRIAL: Ph 2 NuTide:323 CRC Study to be Discontinued Following Pre-Planned Initial Analysis and Recommendation from the Steering Committee September 3, 2024
FDA accepts Supplemental BLA for 1L HCC based on Ph 3 CheckMate -9DW trial demonstrating improved survival with Opdivo + Yervoy vs SoC; PDUFA: Apr 2025 August 27, 2024
Sonnet BioTherapeutics Enters into Clinical Collaboration Agreement for Ph 1/2a Study of SON-1210 + Chemo for the Treatment of Pancreatic Cancer August 22, 2024
First Patient Dosed in Ph 2 Trial of HLX53 + Serplulimab + HANBEITAI for the First-line Treatment of Locally Advanced or Metastatic HCC Patients August 22, 2024
FDA Clears IND Application for Ph 1b Study of PTM-101 for the Localized Treatment of Pancreatic Cancer August 22, 2024
Successful End-of-Phase 2 Meeting with FDA for Amezalpat (TPST-1120) to Treat 1L HCC Announced August 22, 2024
MHRA approves Zolbetuximab for the treatment of Claudin18.2+ve, HER2neg gastric/GEJ cancer August 21, 2024
Enhertu approved in China for patients with previously treated HER2-positive advanced or metastatic gastric cancer August 21, 2024
Enrollment completed in Ph 2/3 COMPANION-002 trial of CTX-009 + paclitaxel in patients with 2L advanced Metastatic or Recurrent Biliary Tract Cancers (BTC) August 13, 2024
FDA Clears IND Application for Ziftomenib in Advanced Gastrointestinal Stromal Tumors (GIST) August 13, 2024
