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TOP STORIES from the week

Vir Biotechnology and Gilead Sciences to Discover and Develop Novel PRO-XTEN® Dual-masked T-cell Engagers for Solid Tumors

VS-7375 Demonstrates 50% Confirmed ORR in 2L Pancreatic Ductal Adenocarcinoma and Two Complete Responses in 2L+ Disease (One Confirmed)

FDA Accepts NDA for UGN-103 in Recurrent LG-IR-NMIBC

Marker Therapeutics Awarded $2.6 Million FDA Orphan Products Development Grant to Advance MT-601 in Pancreatic Cancer

GOBLET Ph 1/2 study Final Cohort 4 results expected in Q4 2026; initial Cohort 5 results expected in H1 2027

FDA approves imlunestrant in combination with abemaciclib for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer

FDA granted Fast Track designation to QTX3034 + cetuximab for KRASG12D-mutant CRC, with or without FOLFOX chemotherapy

Data from FURTHER Ph 1b (FURMO-002) of firmonertinib in 1L EGFR PACC-mutant NSCLC published in Cancer Cell

Opamtistomig Enrolls First Patient in Ph 1b/2 Combination Trial in Metastatic CRC

Marker Therapeutics Awarded $2.6 Million FDA Orphan Products Development Grant to Advance MT-601 in Pancreatic Cancer

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Drug approvals

FDA Expands ANKTIVA® Approval for BCG-Unresponsive NMIBC to Cover Both Papillary and CIS Disease

Jemperli (dostarlimab) approved in US for adults with MSI-H/dMMR locally advanced rectal cancer

TUKYSA Regimen Receives FDA Approval as Front-Line Maintenance Treatment for HER2+ Metastatic Breast Cancer

FDA approved adjuvant Tecentriq and Tecentriq Hybreza in combination with a fluoropyrimidine and oxaliplatin for the treatment of stage III dMMR colon cancer

Regulatory news

FDA Accepts NDA for UGN-103 in Recurrent LG-IR-NMIBC

FDA granted Fast Track designation to QTX3034 + cetuximab for KRASG12D-mutant CRC, with or without FOLFOX chemotherapy

RASONQUE™ (daraxonrasib) Receives Positive CHMP Opinion Recommending Marketing Authorization in European Union for Metastatic Pancreatic Cancer

FDA cleared IND application for LB2501 for R/R B-cell malignancies, including B-cell NHL

Trial results

VS-7375 Demonstrates 50% Confirmed ORR in 2L Pancreatic Ductal Adenocarcinoma and Two Complete Responses in 2L+ Disease (One Confirmed)

Data from FURTHER Ph 1b (FURMO-002) of firmonertinib in 1L EGFR PACC-mutant NSCLC published in Cancer Cell

Positive Ph 2 Final Efficacy Results from Investigator-Sponsored TASKIN Trial in Refractory Metastatic CRC Announced

Efficacy Data presented from Ph 2b CLOVER WaM Subset Analysis of Iopofosine I 131 in Patients Relapsed/Refractory to BTK Inhibitor Therapy

trial status

GOBLET Ph 1/2 study Final Cohort 4 results expected in Q4 2026; initial Cohort 5 results expected in H1 2027

Opamtistomig Enrolls First Patient in Ph 1b/2 Combination Trial in Metastatic CRC

First Patient Dosed in Hong Kong Clinical Trial of PLT012 for Liver Cancer Expansion

First Patient Dosed in Ph 1 Study of MGC030 in Patients with Advanced Solid Tumors

Business news

Vir Biotechnology and Gilead Sciences to Discover and Develop Novel PRO-XTEN® Dual-masked T-cell Engagers for Solid Tumors

Marker Therapeutics Awarded $2.6 Million FDA Orphan Products Development Grant to Advance MT-601 in Pancreatic Cancer

Hansoh Pharma Announces Strategic Collaboration and License Agreement With Roche to Advance Novel ADC Portfolio

Alentis and PinotBio announce collaboration to develop next-generation ADCs targeting claudin-1

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