SAR442085 / Sanofi - LARVOL DELTA

An open-label, first-in-human, single agent, dose escalation study for the evaluation of safety and efficacy of SAR442085 in patients with relapsed or refractory multiple myeloma. (PubMed, Eur J Haematol) - P1 | "The efficacy of SAR442085 was promising in anti-CD38 mAb naïve patients but did not extend to the larger cohort of anti-CD38 mAb pre-treated patients. This observation, along with transient high-grade thrombocytopenia, could potentially limit its clinical use."

Journal • P1 data • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Oncology • Thrombocytopenia

First-in-human Single Agent Study of SAR442085 in Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P1 | N=37 | Completed | Sponsor: Sanofi | Terminated ➔ Completed

Trial completion • Hematological Malignancies • Multiple Myeloma • Oncology

First-in-human Single Agent Study of SAR442085 in Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P1 | N=37 | Terminated | Sponsor: Sanofi | Active, not recruiting ➔ Terminated; Terminated based on sponsor decision (for reasons unrelated to safety, in reviewing Sponsor's evolving portfolio and strategic prioritization)

Trial termination • Hematological Malignancies • Multiple Myeloma • Oncology

First-in-human Single Agent Study of SAR442085 in Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P1 | N=37 | Active, not recruiting | Sponsor: Sanofi | Trial completion date: Dec 2023 ➔ Sep 2023

Trial completion date • Hematological Malignancies • Multiple Myeloma • Oncology

Targeting CD38 in Neoplasms and Non-Cancer Diseases. (PubMed, Cancers (Basel)) - "Daratumumab and isatuximab already received FDA approval, and novel agents such as MOR202, TAK079 and TNB-738 undergo clinical trials. Also, novel therapeutics such as SAR442085 aim to outrank the older antibodies against CD38...This review focuses on targeting CD38 in cancer and non-cancerous diseases using antibodies, cell-based therapies and CD38 inhibitors. We also provide a summary of current clinical trials targeting CD38."

IO biomarker • Journal • Review • Amyloidosis • Gastrointestinal Disorder • Hematological Disorders • Hematological Malignancies • Human Immunodeficiency Virus • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Lymphoma • Multiple Myeloma • Novel Coronavirus Disease • Oncology • Rheumatoid Arthritis • Rheumatology • Systemic Lupus Erythematosus • Transplant Rejection • Transplantation • CD19

First-in-human Single Agent Study of SAR442085 in Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P1 | N=37 | Active, not recruiting | Sponsor: Sanofi | Trial primary completion date: Sep 2023 ➔ Aug 2022

Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology

First-in-human Single Agent Study of SAR442085 in Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P1 | N=37 | Active, not recruiting | Sponsor: Sanofi | Recruiting ➔ Active, not recruiting | N=78 ➔ 37

Enrollment change • Enrollment closed • Hematological Malignancies • Multiple Myeloma • Oncology

SAR442085, a novel anti-CD38 antibody with enhanced antitumor activity against multiple myeloma. (PubMed, Blood) - "Finally, using huFcgR transgenic mice that express human Fcγ receptors under the control of their human regulatory elements, we demonstrated that SAR442085 had higher NK cell-dependent in vivo antitumor efficacy and better survival than daratumumab and isatuximab against EL4 thymoma or VK*MYC myeloma cells overexpressing human CD38. These results highlight the preclinical efficacy of SAR442085 and support the current evaluation of this next-generation anti-CD38 antibody in phase I clinical development in patients with relapsed/refractory MM."

Journal • Hematological Malignancies • Multiple Myeloma • Oncology • Solid Tumor • Thymoma • Thymus Cancer • FCGR2A • FCGR3A

First-in-human Single Agent Study of SAR442085 in Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P1; N=78; Recruiting; Sponsor: Sanofi; Trial completion date: May 2023 ➔ Dec 2023; Trial primary completion date: Jan 2023 ➔ Sep 2023

Clinical • Trial completion date • Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology

First-in-human Single Agent Study of SAR442085 in Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P1; N=78; Recruiting; Sponsor: Sanofi; Trial primary completion date: Oct 2022 ➔ Jan 2023

Clinical • Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology

First-in-human Single Agent Study of SAR442085 in Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P1; N=78; Recruiting; Sponsor: Sanofi; Trial primary completion date: May 2023 ➔ Oct 2022

Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology

First-in-human Single Agent Study of SAR442085 in Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P1; N=78; Recruiting; Sponsor: Sanofi; Trial completion date: Jan 2023 ➔ May 2023; Trial primary completion date: Jan 2023 ➔ May 2023

Clinical • Trial completion date • Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology

Sanofi's emerging oncology pipeline highlighted at the AACR Virtual Annual Meeting II (PRNewswire) - "Preclinical data show anti-tumor activity in Sanofi's investigational compounds, including an oral selective estrogen receptor degrader (SERD) and an anti-CEACAM5 antibody-drug conjugate. Data reinforce Sanofi's commitment to multiple myeloma; include new preclinical findings for Sarclisa® (isatuximab-irfc), and anti-CD38 antibody and CD38/CD28xCD3 trispecific T-cell engager. More than 20 presentations from Sanofi Oncology Research supporting additional investigation of priority compounds in breast, lung and blood cancers….Preclinical data for Sanofi's investigational compounds in breast, lung, multiple myeloma and other cancers will be featured at the American Academy of Cancer Research (AACR) Virtual Annual Meeting II on June 22-24."

Preclinical • Acute Lymphocytic Leukemia • Breast Cancer • Gastrointestinal Cancer • Hematological Malignancies • Lung Cancer • Multiple Myeloma • Non Small Cell Lung Cancer • Oncology

[VIRTUAL] SAR442085, a next generation anti-CD38 antibody with enhanced antibody-dependent cellular cytotoxicity (ADCC) against multiple myeloma (AACR-II 2020) - "Here we describe SAR442085, a next generation anti–CD38 antibody, with higher affinity for the activating FcγRIIIa and FcγRIIa receptors expressed on effector cells as compared to the approved anti–CD38 antibody daratumumab, resulting in greater effector functions. In addition, SAR442085 demonstrated potent in vivo single–agent activity against murine tumor cells expressing human CD38, in a transgenic C57BL/6 mouse model humanized for all Fcγ receptors, with 90% mice survival at 10 and 1.25 mg/kg and up to 90 days median survival time. Overall, these data support the current evaluation of this next generation anti–CD38 antibody in phase I clinical trials in patients with relapsed/refractory MM."

Hematological Malignancies • Multiple Myeloma • Oncology • CD38

First-in-human Single Agent Study of SAR442085 in Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P1; N=78; Recruiting; Sponsor: Sanofi; Trial completion date: Mar 2022 ➔ Jan 2023; Trial primary completion date: Mar 2022 ➔ Jan 2023

Clinical • Trial completion date • Trial primary completion date

First-in-human Single Agent Study of SAR442085 in Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P1; N=78; Recruiting; Sponsor: Sanofi; Initiation date: Jun 2019 ➔ Sep 2019

Clinical • Trial initiation date

First-in-human Single Agent Study of SAR442085 in Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P1; N=78; Recruiting; Sponsor: Sanofi; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open