On 17 February 2025, Formycon announced that it will be prematurely terminating the “Lotus” Phase 3 trial of FYB206, biosimilar to MSD’s Keytruda® (pembrolizumab). According to Formycon, based on “intensive scientific dialogue” with the US FDA, it has concluded that the Phase 3 study is no longer necessary for the development and US approval of FYB206. Instead, Formycon proposes to rely on data from its ongoing Phase 1 trial (“Dahlia”), combined with “a comprehensive analytical program”.
The Phase 1 trial was commenced in June 2024 and is comparing the pharmacokinetics, safety and tolerability of FYB206 with Keytruda® in malignant melanoma. The Lotus Phase 3 trial was commenced in July 2024 to compare the efficacy and safety of FYB206 with Keytruda® in combination with chemotherapy in patients with non-small cell lung cancer (NSCLC).
In October 2024, Formycon announced that results of a comparative analytical evaluation of FYB206, published in Drugs in R&D, showed FYB206 to be structurally and functionally “highly similar” to Keytruda®.
Other pembrolizumab biosimilars in clinical trials include Celltrion’s CT-P51 (Ph 3 trial plan approved by FDA in August 2024), Bio-Thera’s BAT3306 (Ph 1/3 in nsNSCLC commenced 25 July 2024), Amgen’s ABP 234 (Ph 3 in nsNSCLC initiated May 2024), Samsung Bioepis’ SB27 (Ph 3 in metastatic nsNSCLC commenced April 2024) and Sandoz’s GME751 (Ph 1 and 3 commenced in April 2024 (Ph 3)/May 2024 (Ph 1)). In September 2024, Shanghai Henlius Biotech received approval in China for a clinical trial of its pembrolizumab biosimilar, HLX17.