SAR443216 / Sanofi - LARVOL DELTA

SAR443216 Engages HER2 With Manageable Toxicity in Advanced HER2+ Solid Tumors (OncLive) - P1/1b | N=44 | NCT05013554 | Sponsor: Sanofi | "No patients achieved objective response with SAR443216. However, the disease control rate was 35%. Among patients treated at the 2-week lead-in dose level, best responses included progressive disease (PD; n = 19) and stable disease (SD; n = 10). Of note, 2 patients with best responses of PD had no relative change from baseline following treatment. Among patients treated at the 3-week lead-in dose level, best responses included PD (n = 6), SD (n = 4), and not evaluable (NE; n = 1). Of note, 1 patient with a best response of PD and the patient who was NE for had no relative change from baseline following treatment."

P1 data • Oncology • Solid Tumor

Phase I/Ib open-label study of an HER2-targeted T cell engager (TCE)‒SAR443216 in patients (pts) with advanced solid tumors: Intravenous (IV) dose-escalation results (ESMO-TAT 2025) - P1 | "Treatment with TCE SAR443216 in advanced HER2+ solid tumors is feasible with manageable toxicities."

Clinical • Metastases • P1 data • Oncology • Solid Tumor • HER-2 • IL2

Phase I/Ib open-label study of an HER2-targeted T cell engager (TCE)‒SAR443216 in patients (pts) with advanced solid tumors: Intravenous (IV) dose-escalation results (ESMO 2024) - P1 | "Treatment with TCE SAR443216 in advanced HER2+ solid tumors is feasible with manageable toxicities."

Clinical • Metastases • P1 data • Gastric Cancer • Gastrointestinal Cancer • Oncology • Ovarian Cancer • Solid Tumor • HER-2 • IL2

The world's first CD3 X CD28 X HER2 triple antibody clinical data was released, and Sanofi has terminated the development [Google translation] (Sohu.com) - P1/1b | N=44 | NCT05013554 | Sponsor: Sanofi | "The 2024 ESMO Annual Meeting will be held in Barcelona, ​​Spain from September 13 to 17. At this meeting, Sanofi announced for the first time the Phase 1 clinical data of its CD3 X CD28 X HER2 triple antibody SAR443216 in the treatment of advanced solid tumors...Q4 financial report PPT, Sanofi stated that it had abandoned the clinical development of this drug. The data disclosed at this ESMO may provide some reference and thinking for industry insiders...The results of intravenous dose escalation of a Phase I/Ib study (NCT05013554) were selected for this conference...In the study, 3 DLTs were observed , all occurring in DL with 2-week escalation (1 heart failure at 180 μg; 2 elevated transaminases at 720 μg)....No objective response has been observed so far, and the disease control rate is 35% (14/40 patients). Within the explored dose range, PK is mostly proportional to dose, with a terminal T1/2 of 1-2 days."

Discontinued • P1 data • Oncology • Solid Tumor • HER-2

Dose Escalation and Expansion Study of SAR443216 in Participants With Relapsed/Refractory HER2 Expressing Solid Tumors (clinicaltrials.gov) - P1 | N=44 | Terminated | Sponsor: Sanofi | N=200 ➔ 44 | Trial completion date: Feb 2026 ➔ Jan 2024 | Recruiting ➔ Terminated | Trial primary completion date: Feb 2026 ➔ Jan 2024; Sponsor's decision. Termination decision unrelated to safety profile

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A phase I/Ib open-label, first-in-human, single agent, dose escalation and expansion study of a HER2-targeted T cell engager (SAR443216) in patients with relapsed/refractory HER2-expressing solid tumors (ESMO 2023) - P1 | "Nature. 2022; 603:328-334."

Clinical • P1 data • Oncology • Solid Tumor • HER-2

Dose Escalation and Expansion Study of SAR443216 in Participants With Relapsed/Refractory HER2 Expressing Solid Tumors (clinicaltrials.gov) - P1 | N=200 | Recruiting | Sponsor: Sanofi | Trial completion date: Oct 2025 ➔ Feb 2026 | Trial primary completion date: Oct 2025 ➔ Feb 2026

Trial completion date • Trial primary completion date • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

SAR443216: Primary completion and completion of P1 trial (NCT05013554) for solid tumors on October 31, 2025 (Sanofi) - Q4 & FY2022 Results

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

Dose Escalation and Expansion Study of SAR443216 in Participants With Relapsed/Refractory HER2 Expressing Solid Tumors (clinicaltrials.gov) - P1 | N=200 | Recruiting | Sponsor: Sanofi | Trial completion date: Jun 2025 ➔ Sep 2025 | Trial primary completion date: Jun 2025 ➔ Sep 2025

Trial completion date • Trial primary completion date • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HER-2

Dose Escalation and Expansion Study of SAR443216 in Participants With Relapsed/Refractory HER2 Expressing Solid Tumors (clinicaltrials.gov) - P1 | N=184 | Recruiting | Sponsor: Sanofi | Trial completion date: Nov 2025 ➔ Jun 2025 | Trial primary completion date: Nov 2025 ➔ Jun 2025

Trial completion date • Trial primary completion date • Breast Cancer • Gastric Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HER-2

Dose Escalation and Expansion Study of SAR443216 in Participants With Relapsed/Refractory HER2 Expressing Solid Tumors (clinicaltrials.gov) - P1 | N=184 | Recruiting | Sponsor: Sanofi | Trial completion date: Jun 2025 ➔ Nov 2025 | Trial primary completion date: Jun 2025 ➔ Nov 2025

Trial completion date • Trial primary completion date • Breast Cancer • Gastric Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HER-2

Dose Escalation and Expansion Study of SAR443216 in Participants With Relapsed/Refractory HER2 Expressing Solid Tumors (clinicaltrials.gov) - P1; N=184; Recruiting; Sponsor: Sanofi; Not yet recruiting ➔ Recruiting; Trial completion date: Oct 2023 ➔ Jun 2025; Trial primary completion date: Oct 2023 ➔ Jun 2025

Clinical • Enrollment open • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HER-2

Dose Escalation and Expansion Study of SAR443216 in Participants With Relapsed/Refractory HER2 Expressing Solid Tumors (clinicaltrials.gov) - P1; N=184; Not yet recruiting; Sponsor: Sanofi

Clinical • New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HER-2

[VIRTUAL] SAR443216, a novel trispecific T cell engager with potent T cell-dependent cytotoxicity for HER2-low tumors (AACR 2021) - "Finally, in a HER2-low breast cancer xenograft model, SAR443216 also exhibited significant anti-tumor activity in immuno-deficient NSG mice reconstituted with primary human T cells. Thus, SAR443216 represents a promising new drug for cancer patients with HER2-expressing tumors, including those who are currently ineligible for stand-of-care therapy."

Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • BCL2L1 • CD4 • CD8 • GZMB • HER-2 • IL2