Isatuximab Phase 3 Trial Meets Primary Endpoint of Prolonging Progression Free Survival in Patients With Relapsed/Refractory Multiple Myeloma

GUILDFORD, England, Feb. 6, 2019 /PRNewswire/ --

• ICARIA (Isatuximab in Combination with pomalidomide And low-dose dexamethasone veRsus pomalidomide and low dose dexamethasone in patients with refractory or relapsed and refractory Multiple Myeloma), study evaluated the benefit of isatuximab in combination with standard of care in prolonging progression free survival as compared to standard of care in patients with relapsed/refractory multiple myeloma
• Multiple myeloma is the second most common haematological cancer¹
• First randomised Phase 3 trial to evaluate the benefit of adding a monoclonal antibody to pomalidomide and dexamethasone for treatment of relapsed/refractory multiple myeloma

ICARIA, the pivotal Phase 3 trial of isatuximab in patients with relapsed/refractory multiple myeloma, met the primary endpoint of prolonging progression free survival in patients treated with isatuximab in combination with pomalidomide, and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone alone (standard of care).

Results will be submitted to an upcoming medical meeting and are anticipated to form the basis of regulatory submissions planned for later this year.

Commenting on the ICARIA results, Professor Kwee Yong, UK ICARIA Trial Investigator and Professor of Haematology at University College London Hospital explains: "There is a continuing need for new therapeutic options for multiple myeloma in patients who have either relapsed or are no longer responding to their current treatment. The ICARIA study confirms that the investigational agent, isatuximab, in combination with the current standard of care, pomalidomide, improves outcomes for these patients and I'm excited about how these data demonstrate the ability of this investigational compound to extend disease free life in patients living with relapsed/refractory multiple myeloma."

Multiple myeloma is the second most common haematologic cancer,¹ with approximately more than 5,500 people diagnosed each year in the UK at any one time,² it is estimated that 17,500 people are living with this condition.² Multiple myeloma remains incurable in the vast majority of patients, resulting in significant disease burden.³

Dr Marc Moodley, Medical Director for Sanofi Genzyme said: "There is an unmet need in the management of relapsed/refractory multiple myeloma and the ICARIA data represents a significant milestone for Sanofi Genzyme and our oncology portfolio. The isatuximab development programme continues to progress and we are committed to bringing this investigational compound forward as a potential new therapeutic option for patients as soon as possible."

The randomised, multi-centre, open label Phase 3 study, known as ICARIA-MM, enrolled 307 patients with relapsed/refractory multiple myeloma across 96 centres spanning 24 countries. All study participants received two or more prior anti-myeloma therapies, including at least two consecutive cycles of lenalidomide and a proteasome inhibitor given alone or in combination. During the trial, isatuximab was administered through an intravenous infusion at a dose of 10mg/kg once weekly for four weeks, then every other week for 28-day cycles in combination with standard doses of pomalidomide and dexamethasone for the duration of treatment. The safety profile was evaluated as a secondary endpoint.⁴

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References:

1. Kazandjian D. Multiple myeloma epidemiology and survival: A unique malignancy. Semin Oncol. 2016;43 (6):676-681. Available at: https://www.ncbi.nlm.nih.gov/pubmed/28061985. Last accessed February 2019.
2. About Myeloma booklet, Myeloma UK. Available at:
3. https://www.myeloma.org.uk/wp-content/uploads/2018/03/Myeloma-UK-Myeloma-An-Introduction.pdf. Last Accessed February 2019.
4. Smith, D. and Yong, K. (2013). Multiple Myeloma. BMJ. 2013 Jun 26;346:f3863. doi: 10.1136/bmj.f3863. Last accessed February 2019.
5. Clinicaltrials.gov. Multinational Clinical Study Comparing Isatuximab, Pomalidomide, and Dexamethasone to Pomalidomide and Dexamethasone in Refractory or Relapsed and Refractory Multiple Myeloma Patients (ICARIAMM) [Online]. Available at: https://clinicaltrials.gov/ct2/show/record/NCT02990338. Last accessed February 2019. 

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