Key Progress and Upcoming Studies for Pelareorep Breast and Pancreatic Cancer Treatments Announced in Preparation for FDA Accelerated Approval Path October 8, 2024
Interim Ph 2 Data for GRANITE Neoantigen Targeting Immunotherapy in 1L Metastatic MSS CRC Announced October 8, 2024
FDA IND Clearance for ALE.P02, a Novel CLDN1-ADC for the Treatment of Squamous Cancers October 8, 2024
China NMPA approves Cadonilimab for First-Line Treatment of Gastric/GEJ Cancer in All-Comers Population October 8, 2024
Fast Track Designation from the FDA for EO-3021 for the Treatment of Adult Patients with Advanced or Metastatic Gastric or GEJ Cancer Expressing Claudin 18.2 October 2, 2024
EC approved toripalimab (LOQTORZI®) for the treatment of certain patients with mNPC and ESCC October 2, 2024
Anbogen Announces Drug Supply Collaboration with BeiGene to Evaluate Combination Therapy in Colorectal Cancer October 2, 2024
Significant New Data from Ph 2 Trial of LODER™ in Non-Resectable Pancreatic Cancer Announced October 1, 2024
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Supplemental NDA for fruquintinib + paclitaxel for treatment of 2L advanced gastric or GEJ adenocarcinoma voluntarily withdrawn in China September 3, 2024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
