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TOP STORIES from the week

Gotistobart Nearly Doubled Median OS versus SOC Chemo in Previously Treated Squamous NSCLC Patients

Ratio Therapeutics Enters into Research Collaboration and License Agreement with RayzeBio to Advance a Novel Radiopharmaceutical Program

Zipalertinib + chemo Demonstrates 6-Month Median PFS Benefit in REZILIENT3 Ph 3 Trial in 1L EGFR Exon 20 Insertion Mutation NSCLC

FDA clears IND application to initiate Ph 1 study for PRT13722 for HR+/HER2- breast cancer patients

Perspective Therapeutics Announces Clinical Collaboration and Supply Agreement with Merck to Evaluate [212Pb]PSV359 in Combination with Keytruda in FAP-α Positive Solid Tumors

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

FDA “Study May Proceed” Notice and IND Clearance Received for the Evaluation of TBS-2025 in Molecularly Defined Subsets of AML and Other Blood-Related Cancers

Zipalertinib + chemo Demonstrates 6-Month Median PFS Benefit in REZILIENT3 Ph 3 Trial in 1L EGFR Exon 20 Insertion Mutation NSCLC

DSMB recommends termination of Ph 2 trial of adjuvant BNT122-01 in patients with circulating tumor DNA-positive, surgically resected Stage II/III CRC

Perspective Therapeutics Announces Clinical Collaboration and Supply Agreement with Merck to Evaluate [212Pb]PSV359 in Combination with Keytruda in FAP-α Positive Solid Tumors

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Drug approvals

US FDA grants accelerated approval to sevabertinib in 1L HER2-mutant NSCLC

Etcamah + CDK4/6 inhibitor combo approved in the US for 1L advanced HR-positive breast cancer

Enhertu + pertuzumab approved in EU for 1L HER2-positive metastatic breast cancer

FDA Approves Ziihera® (zanidatamab-hrii) with and without Tislelizumab + Chemo in 1L HER2+ Advanced Gastroesophageal Adenocarcinoma

Regulatory news

FDA clears IND application to initiate Ph 1 study for PRT13722 for HR+/HER2- breast cancer patients

FDA “Study May Proceed” Notice and IND Clearance Received for the Evaluation of TBS-2025 in Molecularly Defined Subsets of AML and Other Blood-Related Cancers

US FDA IND Clearance and Australian Regulatory Clearance granted for [²²⁵Ac]Ac-FL-261 Ph 1 Clinical Trial

FDA IND clearance to initiate a first-in-human Ph 1 trial of lead peptide-drug conjugate program TS-104

Trial results

Gotistobart Nearly Doubled Median OS versus SOC Chemo in Previously Treated Squamous NSCLC Patients

Zipalertinib + chemo Demonstrates 6-Month Median PFS Benefit in REZILIENT3 Ph 3 Trial in 1L EGFR Exon 20 Insertion Mutation NSCLC

FAILED TRIAL: SERENA-4 trial of Etcamah + palbociclib did not meet primary objective of statistically significant PFS improvement 

Complete Full Cohort Ph 1 Results for JNJ-1900 (NBTXR3) in Inoperable, Recurrent NSCLC Announced

trial status

First Patient dosed in Ph 1 Trial of CBX-663 for Treatment of Multiple Hematologic and Solid Malignancies

US FDA Allows Continued Treatment for Phase 1 Patient Experiencing Clinical Benefit with HCB101

Focused Development Strategy for Eftilagimod Alfa (“efti”) Outlined

Paxalisib Clinical Trial Expanded into HR+/HER2- Breast Cancer

Business news

Ratio Therapeutics Enters into Research Collaboration and License Agreement with RayzeBio to Advance a Novel Radiopharmaceutical Program

Perspective Therapeutics Announces Clinical Collaboration and Supply Agreement with Merck to Evaluate [212Pb]PSV359 in Combination with Keytruda in FAP-α Positive Solid Tumors

Harbour BioMed Partner, Solstice Oncology, announces $225 Million Series A Financing to Advance Porustobart, a Neoadjuvant Immuno-Oncology Therapy

First Lead Candidate under Amended Strategic Collaboration for Development of Masked CD3 T Cell Engagers Utilizing SAFEbody® Technology

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