Merus’ petosemtamab with Keytruda interim data demonstrated robust efficacy in HNSCC

CLINICAL AND REGULATORY 

Odronextamab BLA accepted for FDA review for the treatment of follicular lymphoma

The efficacy evaluable population consisted of 43 patients who were treated (with one or more doses) as of the data cutoff date and either ≥1 post-baseline tumor assessment, or discontinued early due to disease progression or death. Median follow up of 14.3 months for the 45 patients. In 43 evaluable patients, confirmed ORR was 63% (27/43, 95% CI: 49-75), including 6 complete responses and 21 partial responses. Median PFS was 9 months (95% CI: 5.2-12.9), median duration of response and median OS were not reached. At the time of data cutoff, 14 patients, each of whom are responders, remained on treatment. In 45 patients the combination was generally well tolerated and no significant overlapping toxicities with pembrolizumab were observed.

Belrestotug plus dostarlimab failed in first-line, PD-L1 high NSCLC patients 

iTeos Therapeutics reported topline results from an updated interim analysis of GALAXIES Lung-201, the Phase 2 platform study sponsored by iTeos’ development partner GSK assessing the belrestotug plus dostarlimab doublet in previously untreated, unresectable, locally advanced or metastatic PD-L1 high NSCLC. The GALAXIES Lung-201 data continued to demonstrate clinically meaningful improvements in the trial’s primary endpoint of ORR, however the analysis did not meet established criteria for clinically meaningful improvements in the secondary endpoint of progression free survival in the belrestotug plus dostarlimab combination cohorts versus dostarlimab monotherapy. Additionally, an interim analysis of the GALAXIES H&N-202 Phase 2 trial showed a trend below the meaningful threshold for ORR in the belrestotug combination cohorts vs. dostarlimab monotherapy in PD-L1 positive head and neck squamous cell carcinoma. Based on these results, iTeos and GSK have made the decision to terminate the belrestotug development program and end the collaboration. All belrestotug-containing cohorts are ending, and any new enrollment in the ongoing GALAXIES Lung-301 Phase 3 trial is ending. GSK is communicating with investigators, institutional review boards, ethics committees, and health authorities about next steps for appropriate management of currently enrolled patients. The company is taking immediate steps to preserve capital and has initiated a targeted process to identify opportunities that preserve and maximize shareholder value.

Ivonescimab plus chemo demonstrated clinically meaningful improvement in PFS in NSCLC 

Summit Therapeutics announced topline results from the Phase 3 trial, HARMONi, the first global Phase 3 study evaluating ivonescimab, successfully met the PFS primary endpoint and showed a positive trend in the other primary endpoint, OS. HARMONi is a multiregional, double-blinded, placebo-controlled, Phase 3 study sponsored by Summit evaluating ivonescimab plus platinum-doublet chemotherapy compared to placebo plus platinum-doublet chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI. This is a clinical setting with a patient population where PD-1 monoclonal antibodies have previously been unsuccessful in Phase 3 global clinical trials in showing either a PFS or OS benefit. Approximately 38% of patients were randomized from western countries (ex-Asia), consistent with other recent multiregional Phase III studies in patients with EGFR-mutated NSCLC. At the prespecified primary data analysis, ivonescimab in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in PFS, with a hazard ratio of 0.52 (95% CI: 0.41 – 0.66). There were no new safety signals noted in this Phase 3 study. 

DEALS AND FINANCING 

TILT Biotherapeutics announces closing of €23 million series B financing 

TILT Biotherapeutics, a clinical biotech developing intravenously delivered cancer immunotherapies, announces it has raised €22.6 million in a Series B financing. The financing was supported by existing investors: the European Innovation Council (EIC) Fund, Lifeline Ventures, Finnish Industry Investment (TESI), and Stephen Industries Inc Oy. It will support a Phase 2 clinical trial of Tiltbio’s lead product, TILT-123, in patients with platinum-resistant epithelial ovarian cancer, a Phase 1b trial in melanoma in combination with TILs, and other Phase 1b trials. The reecnt data showed that treatment was well tolerated with an excellent safety profile and promising efficacy observed in some patients. Disease control was achieved in 64% of evaluable patients (9 out of 14), while the ORR was 20% at the highest dose level.