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TOP STORIES from the week

FDA grants Fast Track Designation to iSCIB1+ in advanced melanoma 

JANX008 Clinical Development to be discontinued

Tovecimig Demonstrates Statistically Significant PFS Benefit but misses the OS benefit in COMPANION-002 Ph 2/3 Study in Patients with Biliary Tract Cancer

US FDA Grants Priority Review to TEVIMBRA in 1L HER2+ GEA

Telomir Pharmaceuticals Completes Acquisition of TELI Pharmaceuticals, Securing Global Rights to Telomir-1 (Telomir-Zn)

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

US FDA Grants Priority Review to TEVIMBRA in 1L HER2+ GEA

Ph 3 VIKTORIA-1 Trial Achieves Primary Endpoint With Clinically Meaningful PFS Improvement in PIK3CA Mutant Cohort

First Patient Dosed in Ph 1 Trial of KST-6051 in Patients with KRAS-driven Malignancies

Terremoto Biosciences Closes $108 Million Series C Financing to Advance Selective AKT1-Inhibitors in Oncology

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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

NICE issues Final Draft Guidance recommending RYBREVANT + chemo during managed access period in 1L NSCLC with EGFR ex20ins mutations in adults

Protocol Amendment to NANORAY-312 Ph 3 Head and Neck Cancer Study of for JNJ-1900 (NBTXR3) Announced

FDA Accepts Supplemental NDA for IBTROZI® (taletrectinib) with Updated DoR in Advanced ROS1+ve NSCLC

FDA Commissioner’s National Priority Voucher for BIZENGRI® (Zenocutuzumab-zbco) in NRG1 Fusion-Positive Cholangiocarcinoma

Trial results

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

50% ORR Announced in Recurrent Ovarian Cancer Ph 2 Trial of  Ampligen, Pembrolizumab and Cisplatin

Updated Positive Survival Observations from Ph 1 Trial of Lira-cel Ovarian Cancer CAR-T Therapy Reported

trial status

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

Study initiated to evaluate Pidnarulex (CX-5461) + tislelizumab in pancreatic cancer, colorectal cancer, and melanoma

Development of onvapegleukin alfa discontinued 

JANX008 Clinical Development to be discontinued

Business news

Telomir Pharmaceuticals Completes Acquisition of TELI Pharmaceuticals, Securing Global Rights to Telomir-1 (Telomir-Zn)

Huahui Health and BeOne Medicines Enter into a Global Exclusive Option, License and Collaboration Agreement for Innovative Oncology Drug HH160

Gilead Sciences Completes Acquisition of Arcellx Ahead of Potential Commercial Launch of Anito-cel

Lilly to acquire Ajax Therapeutics to advance outcomes for patients with myelofibrosis and polycythemia vera

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