cobolimab (TSR-022) / AnaptysBio, GSK - LARVOL DELTA

Dostarlimab Plus Cobolimab Improves MPR Rate vs Dostarlimab in High-Risk Resectable Melanoma (OncLive) - P2 | N=62 | NEO-MEL-T (NCT04139902) | "The addition of cobolimab to dostarlimab-gxly (Jemperli) was tolerable and led to efficacy improvements compared with dostarlimab monotherapy for the neoadjuvant treatment of patients with high-risk resectable melanoma, according to data from the phase 2 NEO-MEL-T trial (NCT04139902) presented during the 2025 ASCO Annual Meeting. Findings from the primary analysis of NEO-MEL-T demonstrated that patients who received the combination (n = 27) achieved a major pathological response (MPR) rate of 55.6% and those who received dostarlimab alone (n = 30) experienced an MPR rate of 33.3%. The pathological complete response rates were 37% and 33.3%, respectively. Additionally, 18.5% and 3.7% of patients in the combination arm experienced a pathological major response or a pathological partial response, respectively."

P2 data • Melanoma

Cobolimab and dostarlimab in the first-line treatment of unresectable hepatoma: A multi-center, single arm, phase 2 trial. (ASCO 2025) - P2 | "Cobolimab plus dostarlimab yielded promising response rates and survival outcomes with acceptable safety as first-line treatment in patients with CP A, unresectable HCC. This represents a potential therapy regimen for this population. Clinical trial information: NCT03680508."

Clinical • P2 data • Endocrine Disorders • Hepatocellular Cancer • Liver Cancer • Solid Tumor

Randomized phase II study of neoadjuvant (neoadj) anti-PD-1 dostarlimab (D) vs. D + anti-TIM-3 cobolimab (C) in high-risk resectable melanoma (mel) (NEO-MEL-T): Primary analysis. (ASCO 2025) - P2 | "Neoadj D+C was safe and efficacious. The 1-year EFS of 92% in Arm B was significantly improved relative to adjuvant anti-PD-1, and this combination warrants further investigation. Clinical trial information: NCT04139902."

Clinical • Late-breaking abstract • P2 data • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HAVCR2

Study of the Safety and Effectiveness of GSK6097608 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=107 | Active, not recruiting | Sponsor: GlaxoSmithKline | Recruiting ➔ Active, not recruiting | N=244 ➔ 107 | Trial completion date: Sep 2025 ➔ Dec 2025 | Trial primary completion date: Sep 2025 ➔ Dec 2025

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Colorectal Cancer • Endometrial Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Phase 2 Study of Dostarlimab in Combination with Cobolimab in Advanced Cervical Cancer (SGO 2025) - No abstract available

Combination therapy • Metastases • P2 data • Cervical Cancer • Oncology • Solid Tumor

Anaptys Announces Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update (GlobeNewswire) - "GSK Immuno-Oncology Financial Collaboration: (i) GSK announced strong commercial performance for Jemperli ($190 million in Q4 2024 sales) with >100% year-over-year growth; (ii) GSK anticipates top-line data in H1 2025 from COSTAR Lung Phase 3 trial comparing cobolimab, a TIM-3 antagonist, plus dostarlimab, a PD-1 antagonist, plus docetaxel to dostarlimab plus docetaxel and to docetaxel alone in patients with advanced NSCLC who have progressed on prior anti-PD-(L)1 therapy and platinum-based chemotherapy; (iii) GSK anticipates top-line data in 2026 from AZUR-1 pivotal Phase 2 trial of dostarlimab monotherapy in patients with untreated stage II/III dMMR/MSI-H locally advanced rectal cancer."

P2 data • P3 data: top line • Sales • Endometrial Cancer • Non Small Cell Lung Cancer • Rectal Cancer

A Study of Cobolimab Plus Dostarlimab in Pediatric and Young Adult Participants With Cancer (clinicaltrials.gov) - P1/2 | N=95 | Recruiting | Sponsor: GlaxoSmithKline | Trial completion date: Nov 2030 ➔ Jan 2032 | Trial primary completion date: Aug 2028 ➔ Oct 2029

Trial completion date • Trial primary completion date • Melanoma • Oncology • Pediatrics • Solid Tumor

Cobolimab: Acceptance of regulatory submissions in US/EU (based on COSTAR trial) for 2L NSCLC in H2 2025 (GSK) - Q4 & FY2024 Results: Regulatory decisions in US/EU (based on COSTAR trial) for 2L NSCLC in 2026

EMA approval • EMA filing • FDA approval • FDA filing • Lung Cancer • Non Small Cell Lung Cancer • Oncology

AMBER part 2F: Cobolimab in combination with dostarlimab in treatment-naïve patients with locally advanced/metastatic and/or unresectable hepatocellular carcinoma (HCC). (ASCO-GI 2025) - P1 | "Time-to-event analyses will be performed via Kaplan–Meier methods. After ~25 pts have been followed-up for ≥3 scans, an interim analysis may be performed."

Clinical • Combination therapy • IO biomarker • Metastases • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor • AFP

A Study of Cobolimab Plus Dostarlimab in Pediatric and Young Adult Participants With Cancer (clinicaltrials.gov) - P1/2 | N=95 | Recruiting | Sponsor: GlaxoSmithKline | Not yet recruiting ➔ Recruiting | Initiation date: Sep 2024 ➔ Dec 2024

Enrollment open • Trial initiation date • Melanoma • Oncology • Pediatrics • Solid Tumor

TSR-022 (anti-TIM-3 Antibody) and TSR-042 (anti-PD-1 Antibody) in Patients with Liver Cancer (clinicaltrials.gov) - P2 | N=42 | Active, not recruiting | Sponsor: University of Hawaii | Trial primary completion date: Oct 2024 ➔ Oct 2025

Combination therapy • Metastases • Trial primary completion date • Hepatocellular Cancer • Hepatology • Liver Cancer • Oncology • Solid Tumor

COSTAR Lung: Efficacy Comparison of Cobolimab + Dostarlimab + Docetaxel to Dostarlimab + Docetaxel to Docetaxel Alone in Participants With Advanced Non-Small Cell Lung Cancer Who Have Progressed on Prior Anti- Programmed Death-ligand 1 (PD-[L]1) Therapy and Chemotherapy (clinicaltrials.gov) - P3 | N=758 | Active, not recruiting | Sponsor: GlaxoSmithKline | Phase classification: P2/3 ➔ P3 | Trial primary completion date: Oct 2024 ➔ Apr 2025

Cost of therapy • Metastases • Phase classification • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

TSR-022 (anti-TIM-3 Antibody) and TSR-042 (anti-PD-1 Antibody) in Patients with Liver Cancer (clinicaltrials.gov) - P2 | N=42 | Active, not recruiting | Sponsor: University of Hawaii | Recruiting ➔ Active, not recruiting | Trial completion date: Oct 2025 ➔ Oct 2027

Combination therapy • Enrollment closed • Metastases • Trial completion date • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Liver Cancer • Oncology • Solid Tumor

Anaptys Announces Second Quarter 2024 Financial Results and Provides Business Update (GlobeNewswire) - "GSK anticipates top-line data in H1 2025 from COSTAR Lung Phase 3 trial comparing cobolimab, a TIM-3 antagonist, plus dostarlimab, a PD-1 antagonist, plus docetaxel to dostarlimab plus docetaxel to docetaxel alone in patients with advanced NSCLC who have progressed on prior anti-PD-(L)1 therapy and chemotherapy; GSK anticipates top-line data in H2 2024 from the FIRST Phase 3 trial for platinum-based therapy with dostarlimab and niraparib versus platinum-based therapy as first-line treatment of Stage III or IV nonmucinous epithelial ovarian cancer."

P3 data: top line • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer

A Study of Cobolimab Plus Dostarlimab in Pediatric and Young Adult Participants With Cancer (clinicaltrials.gov) - P1/2 | N=131 | Not yet recruiting | Sponsor: GlaxoSmithKline

Combination therapy • New P1/2 trial • Melanoma • Oncology • Pediatrics • Solid Tumor

Neo-MEL-T: Neoadjuvant PD-1 Inhibitor Dostarlimab (TSR-042) vs. Combination of Tim-3 Inhibitor Cobolimab (TSR-022) and PD-1 Inhibitor Dostarlimab (TSR-042) in Melanoma (clinicaltrials.gov) - P2 | N=56 | Recruiting | Sponsor: Diwakar Davar | Trial completion date: Oct 2027 ➔ Apr 2029 | Trial primary completion date: Jan 2025 ➔ Sep 2025

Metastases • Trial completion date • Trial primary completion date • Melanoma • Oncology • Solid Tumor

Study of Niraparib, TSR-022, Bevacizumab, and Platinum-Based Doublet Chemotherapy in Combination With TSR-042 (clinicaltrials.gov) - P1 | N=58 | Active, not recruiting | Sponsor: Tesaro, Inc. | Trial completion date: Apr 2024 ➔ Aug 2024

Combination therapy • Metastases • Trial completion date • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study of TSR-022 in Participants With Advanced Solid Tumors (AMBER) (clinicaltrials.gov) - P1 | N=475 | Recruiting | Sponsor: Tesaro, Inc. | Trial completion date: Jul 2025 ➔ Apr 2027 | Trial primary completion date: Dec 2024 ➔ Apr 2025

Metastases • Trial completion date • Trial primary completion date • Colorectal Cancer • Hepatocellular Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Anaptys Announces First Quarter 2024 Financial Results and Provides Business Update (GlobeNewswire) - "Updates on GSK Immuno-Oncology Financial Collaboration:...GSK anticipates top-line data in 2025 from COSTAR Lung Phase 3 trial comparing cobolimab, a TIM-3 antagonist, plus dostarlimab, a PD-1 antagonist, plus docetaxel to dostarlimab plus docetaxel to docetaxel alone in patients with advanced NSCLC who have progressed on prior anti-PD-(L)1 therapy and chemotherapy."

P3 data: top line • Non Small Cell Lung Cancer

A Study of TSR-022 in Participants With Advanced Solid Tumors (AMBER) (clinicaltrials.gov) - P1 | N=475 | Recruiting | Sponsor: GlaxoSmithKline

Metastases • New P1 trial • Hepatocellular Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Anaptys Announces Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update (GlobeNewswire) - "Updates on GSK Immuno-Oncology Financial Collaboration: (i) GSK anticipates top-line data in H2 2024 from COSTAR Lung Phase 3 trial comparing cobolimab, a TIM-3 antagonist, plus dostarlimab, a PD-1 antagonist, plus docetaxel to dostarlimab plus docetaxel to docetaxel alone in patients with advanced NSCLC who have progressed on prior anti-PD-(L)1 therapy and chemotherapy; (ii) GSK anticipates top-line data in H1 2024 from the FIRST Phase 3 trial for platinum-based therapy with dostarlimab and niraparib versus platinum-based therapy as first-line treatment of Stage III or IV nonmucinous epithelial ovarian cancer."

P3 data: top line • Non Small Cell Lung Cancer • Ovarian Cancer

TSR-022 (Anti-TIM-3 Antibody) and TSR-042 (Anti-PD-1 Antibody) in Patients With Liver Cancer (clinicaltrials.gov) - P2 | N=42 | Recruiting | Sponsor: University of Hawaii | Trial completion date: Oct 2023 ➔ Oct 2025 | Trial primary completion date: Oct 2022 ➔ Oct 2024

Combination therapy • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Liver Cancer • Oncology • Solid Tumor

Dostarlimab and Cobolimab in Advanced Cervical Cancer (clinicaltrials.gov) - P2 | N=66 | Recruiting | Sponsor: Meghan Shea | Not yet recruiting ➔ Recruiting | Initiation date: Jul 2024 ➔ Mar 2024

Combination therapy • Enrollment open • Metastases • Trial initiation date • Cervical Cancer • Oncology • Solid Tumor

Dostarlimab and Cobolimab in Advanced Cervical Cancer (clinicaltrials.gov) - P2 | N=66 | Not yet recruiting | Sponsor: Meghan Shea

Combination therapy • Metastases • New P2 trial • Cervical Cancer • Oncology • Solid Tumor

Cobolimab/Dostarlimab Combination Shows Initial Efficacy and Safety Signals in Advanced NSCLC (OncLive) - "Based on the findings shown here, and previously reported receptor occupancy, safety [no dose limiting toxicities], pharmacokinetics, pharmacodynamics, and efficacy, 30 mg [of] cobolimab in combination with dostarlimab was confirmed to be the recommended phase 2 dose,' Diwakar Davar, MD, MSc, stated in a presentation of the data....Davar concluded the presentation by highlighting the ongoing phase 2/3 COSTAR trial (NCT04655976). The study is comparing the combination of cobolimab, dostarlimab, and docetaxel with dostarlimab plus docetaxel, and docetaxel alone in patients with relapsed/refractory advanced NSCLC who received prior PD-(L)1 thereapy."

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