The Janssen Pharmaceutical Companies of Johnson & Johnson have proudly unveiled a significant advancement in cancer treatment. The European Commission (EC) has granted approval for a Type II variation application for Tecvayli (teclistamab), offering a groundbreaking dosing flexibility of 1.5mg/kg every two weeks. This tailored dosing regimen is aimed at patients who have achieved a commendable complete response (CR) or better for a minimum of six months.
Notably, Tecvayli marked a momentous milestone as the first bispecific antibody to secure approval in Europe for addressing relapsed and refractory multiple myeloma (RRMM) in adult patients. This approval is specifically intended for those who have undergone a minimum of three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, and have encountered disease progression during their most recent treatment.
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“Following the initial European Commission approval for teclistamab in August 2022, our research has remained focused on how we can continue to advance the use of teclistamab to better meet individual patient needs and improve patient experiences. Today’s approval for teclistamab provides eligible patients, their caregivers and physicians an additional, more flexible weight-based option with less frequent dosing depending on a patient’s response.”
– Edmond Chan, MBChB M.D. (Res), Senior Director EMEA Therapeutic Area Lead Haematology, Janssen-Cilag Limited
Crucially, the EC’s approval rests upon the robust outcomes of the Phase 1/2 MajesTEC-1 study, which delved into the safety and efficacy of Tecvayli in patients grappling with RRMM.
Fresh insights from this study were recently unveiled at both the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting and the 2023 European Hematology Association (EHA) Congress (8-11 June, Frankfurt). The study encompassed patients who had undergone a median of five prior lines of therapy. After an initial phase, patients were initiated on the recommended Phase 2 dose (RP2D) of 1.5 mg/kg teclistamab on a weekly basis, delivered subcutaneously. Those who achieved a confirmed partial response (PR) or better after four or more cycles (Phase 1), or a confirmed CR or better for a minimum of six months (Phase 2), were eligible for a reduced dosing frequency of 1.5 mg/kg subcutaneously every two weeks (Q2W), sustained until disease progression or intolerable side effects.
Out of the responders, a group of 104 patients transitioned to the Q2W dosing regimen. The outcomes were striking, with 85.7% achieving a CR or better, 12.7 percent attaining a very good partial response (VGPR), and 1.6% achieving a PR at the time of the switch. The median duration of response was promising, with 68.7% of patients sustaining their response for two or more years since their initial response. Moreover, the occurrence of Grade 3 or higher infections in responders who switched to Q2W dosing on or before 12 months was lower compared to those who remained on QW dosing. Importantly, a significant 65% of patients remained on treatment as of the data cut-off.
This accomplishment not only demonstrates a refined approach to cancer treatment but also underscores the importance of tailoring therapies to individual patient responses, offering new hope to those navigating the complexities of RRMM.
