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TOP STORIES from the week

Supplemental NDA for Sacituzumab Tirumotecan (sac-TMT) in Combination with Pembrolizumab in 1L PD-L1+ve NSCLC Accepted for Review by NMPA 

Erasca Announces Clinical Trial Collaboration and Supply Agreement with Merck to Evaluate ERAS-0015 in Combination with KEYTRUDA

First Patient Dosed in ASPENOVA Ph 3 Trial of Azenosertib in Patients with Cyclin E1-Positive Platinum-Resistant Ovarian Cancer

Positive 12-Month Follow-Up Data from Ph 2b CLOVER WaM Study Shows Durable Responses & Efficacy of Iopofosine I 131 in R/R Waldenström Macroglobulinemia

FDA cleared IND for Ph 1/2 study of oral elraglusib in metastatic melanoma, NSCLC, colorectal, and pancreatic cancers

FDA Approves Lifyorli™ (relacorilant) Plus Nab-Paclitaxel for Treatment of Patients with Platinum-Resistant Ovarian Cancer

FDA cleared IND for Ph 1/2 study of oral elraglusib in metastatic melanoma, NSCLC, colorectal, and pancreatic cancers

Evorpacept + Zanidatamab combo Generates Durable Response in Patients with Advanced HER2+ve Breast Cancer and High CD47 Expression

First patient dosed in clinical trial of EDV™ (EnGeneIC Dream Vector) therapy in patients with recurrent GBM

Halozyme Announces Global Collaboration and License Agreement with GSK to Develop SC Formulations of Multiple Promising Oncology Targets

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Drug approvals

FDA Approves BIZENGRI® (Zenocutuzumab-zbco) for NRG1 Fusion-Positive Cholangiocarcinoma Following Receipt of FDA Commissioner’s National Priority Voucher

FDA Approves VEPPANU (vepdegestrant) for the Treatment of ESR1m, ER+/HER2- Advanced Breast Cancer

FDA Approves Jakafi XR™ (ruxolitinib) Extended-Release Tablets for the Treatment of Myelofibrosis

Ojemda® approved in the EU in R/R pediatric low-grade glioma regardless of BRAF alteration

Regulatory news

Supplemental NDA for Sacituzumab Tirumotecan (sac-TMT) in Combination with Pembrolizumab in 1L PD-L1+ve NSCLC Accepted for Review by NMPA 

FDA cleared IND for Ph 1/2 study of oral elraglusib in metastatic melanoma, NSCLC, colorectal, and pancreatic cancers

Fast Track Designation granted for RPTR-1-201 in TNBC

NICE issues Final Draft Guidance recommending RYBREVANT + chemo during managed access period in 1L NSCLC with EGFR ex20ins mutations in adults

Trial results

Positive 12-Month Follow-Up Data from Ph 2b CLOVER WaM Study Shows Durable Responses & Efficacy of Iopofosine I 131 in R/R Waldenström Macroglobulinemia

Evorpacept + Zanidatamab combo Generates Durable Response in Patients with Advanced HER2+ve Breast Cancer and High CD47 Expression

Interim Results Announced of US Alpha DaRT® REGAIN Trial, with 100% Local Disease Control, 67% CRR, and Favorable Safety Profile 

Updated Interim Results Announced From LEGEND Cohort of detalimogene voraplasmid in high-risk, BCG-unresponsive NMIBC patients with CIS with or without concomitant papillary disease

trial status

First Patient Dosed in ASPENOVA Ph 3 Trial of Azenosertib in Patients with Cyclin E1-Positive Platinum-Resistant Ovarian Cancer

First patient dosed in clinical trial of EDV™ (EnGeneIC Dream Vector) therapy in patients with recurrent GBM

Ph 2 Trial of SurVaxM for Patients with Metastatic Neuroendocrine Tumors initiated

First Patient dosed in Ph 1b/2 Trial of PIKTOR in HR+/HER2- Advanced Breast Cancer

Business news

Erasca Announces Clinical Trial Collaboration and Supply Agreement with Merck to Evaluate ERAS-0015 in Combination with KEYTRUDA

Halozyme Announces Global Collaboration and License Agreement with GSK to Develop SC Formulations of Multiple Promising Oncology Targets

UCB, Cancer Research UK and Cancer Research Horizons announce new strategic alliance to accelerate development of novel cancer therapies

Cytospire Therapeutics oversubscribed £61M ($83m) Series A financing to advance pan-gamma delta T cell engagers into clinical trials for the treatment of cancer

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