Roche's Immunotherapy Approved as Adjuvant in Colon Cancer; Endeavor's IPF Hedgehog Inhibitor Hits Phase 2b Endpoints | Industry News

Roche's Tecentriq (atezolizumab) won FDA approval as adjuvant therapy for stage III dMMR colon cancer, cutting recurrence or death risk by 50%; Endeavor's Hedgehog-pathway inhibitor taladegib (ENV-101) met primary and key secondary endpoints in a Phase 2b IPF trial; Lilly's Taltz+Zepbound Phase 3b revealed immuno-metabolic links in psoriasis and obesity.

Roche's Tecentriq approved as adjuvant therapy in stage III dMMR colon cancer

Roche announced today that the US FDA approved Tecentriq (atezolizumab) and its subcutaneous formulation Tecentriq Hybreza (atezolizumab and hyaluronidase), each combined with a fluoropyrimidine and oxaliplatin, for adjuvant treatment after surgery in patients with stage III deficient mismatch repair (dMMR) colon cancer. The company noted this is the first FDA approval of an immune adjuvant therapy for stage III dMMR colon cancer, based primarily on the Phase 3 ATOMIC study.

ATOMIC was a multicenter, randomized, open-label, active-controlled Phase 3 trial in 712 patients with resected stage III dMMR colon cancer, randomized 1:1 to Tecentriq plus mFOLFOX6 for 12 cycles followed by Tecentriq monotherapy for 13 cycles, or mFOLFOX6 for 12 cycles. The primary endpoint was disease-free survival (DFS). Tecentriq combination reduced the risk of recurrence or death by 50% versus the active-control arm; at month 36, DFS rate was 86% versus 76%. The safety profile was consistent with known Tecentriq and mFOLFOX6 characteristics. Tecentriq is a PD-L1-targeted checkpoint inhibitor that helps restore T-cell antitumor activity by blocking PD-L1 interactions with PD-1 and B7.1.

Endeavor's taladegib meets Phase 2b primary and key secondary endpoints in IPF

Endeavor BioMedicines reported positive topline results from the Phase 2b WHISTLE-PF trial of taladegib (ENV-101), an oral Hedgehog-pathway inhibitor, in idiopathic pulmonary fibrosis (IPF): the trial met its primary endpoint, with a statistically significant improvement in ppFVC from baseline at week 24 versus placebo, and multiple key secondary endpoints were also significant. The company plans to discuss a Phase 3 program with global regulators.

WHISTLE-PF was a 24-week, randomized, double-blind, placebo-controlled, dose-finding Phase 2b study in 213 IPF patients across 74 sites in 14 countries; 73% also received standard antifibrotic therapy. Beyond the ppFVC primary endpoint, taladegib showed statistically significant improvements versus placebo on total lung capacity (TLC), quantitative total interstitial lung disease and quantitative fibrosis proportions on HRCT, and absolute FVC. The drug inhibits the Hedgehog pathway — aberrantly activated in fibrotic lung disease and promoting scar formation — and holds FDA and EMA orphan-drug designation plus EMA PRIME status.

Lilly's Taltz + Zepbound Phase 3b reveals immuno-metabolic links

Eli Lilly reported prespecified exploratory analyses from the Phase 3b TOGETHER-PsO study evaluating Taltz (ixekizumab, an IL-17A monoclonal antibody) plus Zepbound (tirzepatide, a GIP/GLP-1 dual agonist) in adults with moderate-to-severe plaque psoriasis who are obese or overweight with at least one weight-related comorbidity. The new analyses linked combination therapy to broader shifts in psoriasis, immune and metabolic biomarkers.

TOGETHER-PsO was a 52-week, randomized, investigator-blinded, open-label Phase 3b study in 274 patients randomized 1:1 to Taltz alone or Taltz plus Zepbound, with lifestyle guidance. At week 36, the combination arm showed 482 differentially expressed proteins and 467 differentially expressed genes versus 140 and 16 in the active-control arm, emerging as early as week 12 and spanning psoriasis inflammation, immune and metabolic pathways; changes in neutrophil-related inflammatory markers may mediate some of the additional skin improvement. The study had previously met its primary endpoint (PASI 100 and ≥10% weight loss at week 36), with maintenance or improvement at week 52 and no new safety signals.