The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the European Commission (EC) has approved a Type II variation application for TECVAYLI® (teclistamab), allowing for a 1.5mg/kg every two weeks dosing frequency in patients who have achieved a complete response (CR) or better for a minimum of six months.
The company has also announced US approval of Tecvayli in multiple myeloma. Read more on this news by clicking on the following Link: https://pharmaquotient.com/jnj-expands-cancer-portfolio-with-talvey-approval/
Clinical Trials for EU approval of TECVAYLI:
Positive results from the Phase 1/2 MajesTEC-1 study (Phase I: NCT03145181; Phase II: NCT04557098) examining the safety and efficacy of teclistamab in patients with RRMM aided the EC approval.
The study’s most recent findings were recently presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in 2023 (2-6 June, Chicago) and the European Haematology Association (EHA) Congress in 2023 (8-11 June, Frankfurt).
Details of the data readout:
Patients in the study had received a median of five prior lines of therapy (range, 2-14) and were started on the recommended Phase 2 dose (RP2D) of 1.5 mg/kg teclistamab weekly (QW) delivered subcutaneously.
Patients who had a confirmed partial response (PR) or better after four or more cycles of treatment (Phase 1), or a confirmed CR or better for six months or longer (Phase 2), were eligible to reduce their dosing frequency to 1.5 mg/kg subcutaneously every two weeks (Q2W) until disease progression or unacceptable toxicity.
63 individuals were shifted to Q2W dosage after receiving teclistamab at the RP2D. The investigation found that 85.7 percent of patients had a CR or better at the time of switch, 12.7 percent achieved a very good partial response (VGPR), and 1.6 percent achieved a PR. The median time it took to transition from the first QW to the first Q2W dose was 11.3 months (range, 3-30).
The median length of response was not yet attained at a median follow-up of 12.6 months (range, 1-25 since switching), and 68.7 percent (95 percent CI, 53.6-79.7) of patients who switched stayed in response for two or more years from the time of first reaction.
After 12-18 months of follow up, the new onset of Grade 3 or higher infections was lower in responders who switched to Q2W dosing on or before 12 months compared to those who remained on QW dosing at 12 months (15.6 percent vs. 33.3 percent). At the time of the data cutoff, 41 patients (65%) were still receiving treatment.
Experts Opinion on EU approval of TECVAYLI:
“When advancing immune-based therapies such as teclistamab, tailored approaches are essential to allow us to respond to evolving data and evidence to find the most suitable balance of efficacy and safety,” said Sen Zhuang, M.D., Ph.D., Vice President, Clinical Research and Development, Janssen Research & Development, LLC. “Today’s approval reinforces our focus on strengthening our multiple myeloma portfolio by investing in cutting-edge research that will help us continue to improve patient outcomes and importantly, their quality of life.”
“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,” said Edmond Chan, MBChB M.D. (Res), Senior Director EMEA Therapeutic Area Lead Haematology, Janssen-Cilag Limited. “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.”
“Every patient’s experience with multiple myeloma is unique and requires a different treatment approach, tailored to their specific needs,” said Niels van de Donk, M.D., Professor of Hematology at Amsterdam University Medical Centers. “With a decreased incidence of new onset Grade 3 or higher infections, low discontinuation rates and depth of responses maintained, this biweekly dosing option for teclistamab could provide substantial benefit for people living with multiple myeloma, potentially offering reduced time spent in hospital.”
Multiple Myeloma:
Multiple myeloma is an incurable blood cancer that affects plasma cells, a kind of white blood cell found in the bone marrow. These malignant plasma cells alter and develop out of control in multiple myeloma.
In Europe in 2020, more than 50,900 persons were diagnosed with multiple myeloma, and more than 32,400 died.
While some individuals with multiple myeloma have no symptoms at first, others may experience common symptoms such as bone fracture or pain, low red blood cell counts, weariness, excessive calcium levels, or renal failure.
Teclistamab (TECVAYLI):
Teclistamab was the first bispecific antibody targeting B-cell maturation antigen (BCMA) on multiple myeloma cells and CD3 on T-cells to be approved in Europe for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM) who have received at least three prior therapies, including an immuno-modulatory agent, a proteasome inhibitor, and an antiCD38 antibody, and have demonstrated disease progression on the last therapy.
