On December 5, 2020 Amgen (NASDAQ:AMGN) reported the first presentation of clinical safety and efficacy data from the Phase 1 study of AMG 701 in heavily pre-treated patients with relapsed/refractory multiple myeloma (R/R MM) (Press release, Amgen, DEC 5, 2020, View Source [SID1234572265]). AMG 701 is an investigational half-life extended (HLE) bispecific T cell engager (BiTE) immuno-oncology therapy targeting B-cell maturation antigen (BCMA). The data will be presented during a live oral presentation on Dec. 5 at the virtual 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition.

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"The emerging data from the BiTE platform in hematological malignancies are encouraging. Previously, Amgen provided important evidence for BCMA-directed BiTE molecules as a therapeutic approach in multiple myeloma. AMG 701 continues to show the potential of that strategy in patients who are heavily pre-treated," said David M. Reese, M.D., executive vice president of Research and Development at Amgen.

"These data are the latest in a series that reinforce both the potential versatility of the BiTE platform and Amgen’s commitment to developing innovative medicines for novel targets in difficult-to-treat cancers," Reese continued. "This year alone, Amgen has presented proof-of-concept data for four BiTE molecules in hematological malignancies and solid tumors, and we are proud to end the year with these data in multiple myeloma at ASH (Free ASH Whitepaper)."

This interim analysis of the Phase 1 dose escalation study evaluated AMG 701 in 85 R/R MM patients who had received at least three prior lines of therapy, and a median of six lines. The response rate was 36% at doses of 3-18 mg with responses lasting up to 26 months in one patient. Six of seven patients, who were tested for minimal residual disease (MRD), were MRD-negative. In the most recent evaluable cohort, there was an 83% ORR, with 4/5 responders being triple refractory.

"Despite advances in the treatment of multiple myeloma, there remains an unmet need for patients with this difficult-to-treat disease who have relapsed or refractory disease following current standard therapies," said Professor Simon J. Harrison, director of the Centre of Excellence in Cellular Immunotherapy, Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, Australia. "These first-in-human data show that AMG 701, a half-life extended BiTE therapy targeting BCMA, has encouraging signs of activity as a single agent in this heavily pre-treated patient population."

The most common hematological adverse events (AEs) were anemia (42%), neutropenia (25%) and thrombocytopenia (21%). The most common non-hematological AEs were cytokine release syndrome (CRS, 65%), diarrhea (31%) and hypophosphatemia (31%). CRS was mostly grade 1 (27%) or 2 (28%) based on Lee Blood 2014 criteria. All Grade 3 CRS events (9%) were reversible with mitigation procedures outlined in the study protocol, with a median duration of two days.

Learn more about Amgen’s development of innovative medicines for novel targets in difficult-to-treat tumors at AmgenOncology.com/medical, and follow Amgen Oncology on Twitter and LinkedIn.

About BiTE Technology

BiTE (bispecific T cell engager) technology is a targeted immuno-oncology platform that is designed to engage patient’s own T cells to any tumor-specific antigen, activating the cytotoxic potential of T cells to eliminate detectable cancer. The BiTE immuno-oncology platform has the potential to treat different tumor types through tumor-specific antigens. The BiTE platform has a goal of leading to off-the-shelf solutions, which have the potential to make innovative T cell treatment available to all providers when their patients need it. Amgen is advancing more than a dozen BiTE molecules across a broad range of hematologic malignancies and solid tumors, further investigating BiTE technology with the goal of enhancing patient experience and therapeutic potential. To learn more about BiTE technology, visit www.AmgenBiTETechnology.com.

About Multiple Myeloma

Multiple myeloma is an incurable blood cancer, characterized by a recurring pattern of remission and relapse.1 It is a rare and life-threatening disease that accounts for approximately one percent of all cancers.2,3 Worldwide, approximately 160,000 people are diagnosed with multiple myeloma each year, and 106,000 patient deaths are reported on an annual basis.2

About Amgen Oncology

Amgen Oncology is searching for and finding answers to incredibly complex questions that will advance care and improve lives for cancer patients and their families. Our research drives us to understand the disease in the context of the patient’s life – not just their cancer journey – so they can take control of their lives.

For the last four decades, we have been dedicated to discovering the firsts that matter in oncology and to finding ways to reduce the burden of cancer. Building on our heritage, Amgen continues to advance the largest pipeline in the Company’s history, moving with great speed to advance those innovations for the patients who need them.

At Amgen, we are driven by our commitment to transform the lives of cancer patients and keep them at the center of everything we do.