Ph 3 CheckMate -8HW Trial of Opdivo + Yervoy vs Chemo in MSI-H or MRD Metastatic CRC Meets Primary endpoint December 11, 2023
Clinical trials of nanrilkefusp alfa as monotherapy and in combinations with pembrolizumab and cetuximab to be discontinued October 18, 2023
MHLW approves Phesgo, the Fixed-Dose Subcutaneous Combination of Perjeta and Herceptin for HER2-Positive Breast and Colorectal Cancer October 3, 2023
European Commission Approves LONSURF® (Trifluridine/tipiracil) in Combination With Bevacizumab in 3rd Line Refractory mCRC August 9, 2023
2nd Positive Interim Trial Data Readout announced in R/R mCRC in Ph 1b/2a IMX-110 IMMINENT-01 Trial July 27, 2023
Initiation of Randomized Controlled Part B of the DeFianCe Study of DKN-01 in Colorectal Cancer Patients Announced July 19, 2023
Botensilimab/Balstilimab Combination Achieves Unprecedented Survival in Advanced Colorectal Cancer July 12, 2023
FDA Approves FoundationOne®LiquidCDx as a Companion Diagnostic for BRAFTOVI + Cetuximab combo to Identify Patients With BRAF V600E Alterations in mCRC June 14, 2023
NDA for Fruquintinib for Treatment of Previously Treated mCRC Granted Priority Review; PDUFA: Nov 2023 May 31, 2023
NMPA Breakthrough Designation for IBI351 (KRASG12C Inhibitor) as Monotherapy for Previously Treated Advanced Colorectal Carcinoma May 18, 2023
Early Positive IMX-110 Interim Data shows 100% Tumor Shrinkage in Advanced mCRC at the Lowest Dose of IMX-110 + Tislelizumab May 10, 2023
U.S. FDA Accepts for Priority Review Supplemental NDA for the Use of Trifluridine/Tipiracil (LONSURF®) in Combination With Bevacizumab for Refractory mCRC April 27, 2023
Enrollment completes in Part A of the DeFianCe Study of DKN-01 for the Treatment of Colorectal Cancer Patients April 20, 2023
FAILED TRIALS: Ph 3 LEAP-003 trial of KEYTRUDA + LENVIMA in 1L metastatic melanoma to be discontinued; combo’s Ph 3 LEAP-017 trial in 1L pMMR mCRC didn’t meet primary endpoint of OS improvement April 12, 2023
First Patient Dosed in ONSEMBLE Ph 2 Randomized Trial of Onvansertib in Patients with mCRC April 6, 2023
Rolling Submission of NDA to U.S. FDA for Fruquintinib for the Treatment of Refractory mCRC completed April 6, 2023
Leap Therapeutics Provides Update on BeiGene Option Agreement for DKN-01; DisTinGuish Trial of DKN-01 + tislelizumab & chemo to continue as a clinical collaboration March 31, 2023
Trilaciclib Ph 3 PRESERVE 1 trial in CRC patients to discontinue after absence of efficacy signals in early data February 22, 2023
US FDA Advisory Committee votes in support of trials designed to evaluate Jemperli as a potential treatment for MMR-D/MSI-high locally advanced rectal cancer February 22, 2023
