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TOP STORIES from the week

Strong Initial Efficacy Data Reported in 3L NSCLC from Ph 2 THIO-101 Part C Expansion Trial 

FDA Clears IND for UGN-501 for Non-Muscle Invasive Bladder Cancer

Biocytogen and Whitehawk Therapeutics Enter Global Collaboration for Bispecific Antibody ADC Development

Jemperli achieves sustained clinical complete responses in dMMR/MSI-H locally advanced rectal cancer

FDA Accepts NDA for Mezigdomide in Patients with Relapsed or Refractory Multiple Myeloma; PDUFA: May 2027

FDA Approves KEYTRUDA and KEYTRUDA QLEX each with Trodelvy as 1L Treatment of PD-L1+ (CPS ≥10) Advanced TNBC

FDA Accepts NDA for Mezigdomide in Patients with Relapsed or Refractory Multiple Myeloma; PDUFA: May 2027

Jemperli achieves sustained clinical complete responses in dMMR/MSI-H locally advanced rectal cancer

First patient dosed in RASolute 305 Ph 3 Trial of Zoldonrasib-Chemo combo in 1L RAS G12D Metastatic Pancreatic Cancer 

FORE Biotherapeutics Announces Closing of Upsized $67.4 Million Series D-2 Extension Financing and Highlights Recent Plixorafenib Achievements

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Drug approvals

FDA approves SC Sarclisa (isatuximab-irfc) Escena + SOC for multiple myeloma patients across all existing indications of Sarclisa IV formulation

FDA Approves REVTORPYK (gedatolisib) for the Treatment of HR+/HER2-, PIK3CA WT Locally Advanced or Metastatic Breast Cancer

FDA Approves KEYTRUDA and KEYTRUDA QLEX, Each With Padcev, as Treatment Before and After Surgery for Adults With MIBC

TEPKINLY (epcoritamab) in Combination with Lenalidomide & Rituximab Approved by the European Commission for the Treatment of R/R Follicular Lymphoma

Regulatory news

FDA Clears IND for UGN-501 for Non-Muscle Invasive Bladder Cancer

FDA Accepts NDA for Mezigdomide in Patients with Relapsed or Refractory Multiple Myeloma; PDUFA: May 2027

FDA Grants Fast Track Designation to SOT109 in CRC

FDA sends CRL for Combination of Rivoceranib and Camrelizumab as 1L Treatment for Unresectable or Metastatic HCC

Trial results

Strong Initial Efficacy Data Reported in 3L NSCLC from Ph 2 THIO-101 Part C Expansion Trial 

Jemperli achieves sustained clinical complete responses in dMMR/MSI-H locally advanced rectal cancer

Global Ph 3 study of HBI-8000 plus nivolumab met the PFS primary endpoint in frontline patients with advanced melanoma

Publication in The JCO Demonstrating DeltEx DRI Doubles PFS in Newly Diagnosed Glioblastoma

trial status

First solid tumour patient dosed with ZI-MA4-1 in the ZIMA-101 Ph 1 trial

FDA Registration-Enabling Ph 3 Confirmatory Study of Multikine® launched in Newly Diagnosed Head and Neck Cancer

CAR001 Ph 1 safety validation completed and Ph IIa solid tumor market trial initiated 

Ph 3 AURORA Trial of Aglatimagene Besadenovec (CAN-2409) in Advanced NSCLC Patients with Inadequate Response to Immune Checkpoint Inhibitors initiated

Business news

Biocytogen and Whitehawk Therapeutics Enter Global Collaboration for Bispecific Antibody ADC Development

FORE Biotherapeutics Announces Closing of Upsized $67.4 Million Series D-2 Extension Financing and Highlights Recent Plixorafenib Achievements

Allotera Therapeutics (Formerly Wugen) Closes $35 Million Financing to Advance Off-the-Shelf CAR-T Therapies for T-Cell Cancers

Agenus Announces Oversubscribed Private Placement of Up to $340 Million to Advance Registrational ROBBIN Trial of Neoadjuvant BOT+BAL in MSS Colon Cancer

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