On August 24, 2022 The Janssen Pharmaceutical Companies of Johnson & Johnson reported that the European Commission (EC) has granted conditional marketing authorisation (CMA) of TECVAYLI▼ (teclistamab) as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM) (Press release, Johnson & Johnson, AUG 24, 2022, View Source [SID1234618675]). Patients must have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.1 Today’s milestone marks the first approval worldwide for teclistamab, a first-in-class bispecific antibody that redirects CD3-positive T-cells to B-cell maturation antigen (BCMA)-expressing myeloma cells to induce the killing of tumour cells.1

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Multiple myeloma remains an incurable blood cancer, with nearly all patients relapsing and requiring subsequent therapy.2,3 As the disease progresses, relapses for patients become more aggressive with each new line of therapy, and remissions become progressively shorter.4

"Despite important scientific progress, patients who develop relapsed and refractory disease after having been exposed to the three major drug classes have limited therapeutic options and generally face poor outcomes," said Maria-Victoria Mateos, M.D., Ph.D., Consultant Physician in Haematology, University Hospital of Salamanca.* "Teclistamab has the potential to provide substantial clinical benefit and new hope to these patients, with high rates of deep and durable responses, and the added convenience of being off-the-shelf."

"The approval of teclistamab followed an accelerated approval pathway, supported via the EMA’s PRIME scheme," said Edmond Chan, MBChB M.D. (Res), Senior Director EMEA Therapeutic Area Lead Haematology, Janssen-Cilag Limited. "We would like to thank the medical community for recognising the promise of teclistamab. Multiple myeloma is a complex disease that requires a complex set of solutions. Only by working together can we ensure that patients are able to benefit from innovation, such as teclistamab, as early as possible."

CMA is the approval of a medicine that addresses unmet medical needs of patients based on less comprehensive data than normally required, where the benefit of immediate availability of the medicine outweighs the risk, and the applicant is able to provide comprehensive clinical data in the future.5

The CMA was supported by positive results from the multicohort, open-label Phase 1/2 MajesTEC-1 study (NCT03145181 and NCT04557098), evaluating the safety and efficacy of teclistamab in adults with RRMM (n =165).1,6,7 Patients received a weekly subcutaneous injection of teclistamab at a dose of 1.5 mg/kg, after receiving step-up doses of 0.06 mg/kg and 0.3 mg/kg.1 In the study, 104 out of 165 patients achieved an overall response rate (ORR) of 63 percent (95 percent Confidence Interval [CI]; range, 55.2–70.4) after a median of five prior lines of therapy.1 Notably, 58.8 percent of patients receiving teclistamab achieved a very good partial response (VGPR) or better and 39.4 percent achieved a complete response (CR) or better.1 The median time to the first confirmed response was 1.2 months (range, 0.2–5.5 months) and the median duration of response was 18.4 months (95 percent CI; range, 14.9–not estimable).1

Results from the MajesTEC-1 study were also published in The New England Journal of Medicine and showed that treatment with teclistamab resulted in deep and durable responses.8 The median duration of progression-free survival was 11.3 months (95 percent CI; range, 8.8–17.1) and the median duration of overall survival was 18.3 months (95 percent CI; range, 15.1–not estimable).8

Adverse events (AEs) were consistent with this patient population. The most common AEs were cytokine release syndrome (72 percent; 0.6 percent Grade 3, no Grade 4), neutropenia (71 percent; 64 percent Grade 3 or 4) and anaemia (55 percent; 37 percent Grade 3 or 4).1 Infections were frequent with the most common being upper respiratory tract infections (37 percent; 2.4 percent Grade 3 or 4) and pneumonia (28 percent; 19 percent Grade 3 or 4).1 Hypogammaglobinaemia occurred in 123 patients (75 percent) and 39 percent of patients received intravenous or subcutaneous immunoglobulin therapy.1 Neurotoxic events were low grade (15 percent; 14 percent Grade 1 or 2) and five patients (three percent) had immune effector cell-associated neurotoxicity syndrome.1

"With nearly 20 years of dedicated leadership in this area, our ambition to advance the best science to deliver novel therapies and regimens for the treatment of multiple myeloma is as strong today as it has ever been. We now look forward to collaborating with health authorities worldwide to make this treatment available to patients," said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC.

"This first approval for teclistamab worldwide marks significant progress for patients with relapsed and refractory multiple myeloma," said William N. Hait, M.D., Ph.D., Executive Vice President, Chief External Innovation, Medical Safety and Global Public Health Officer, Johnson & Johnson. "Teclistamab is an important addition to our multiple myeloma portfolio. We are continuing to invest in clinical development to expand its potential and offer novel options for patients and physicians."

#ENDS#

About Teclistamab

Teclistamab is a first-in-class, off-the-shelf (ready to use) bispecific antibody.1 Teclistamab, a subcutaneous injection, redirects T-cells through two cellular targets (BCMA and CD3) to activate the body’s immune system to fight the cancer.1

The application for conditional marketing authorisation was reviewed by the Committee for Medicinal Products for Human Use (CHMP) under an accelerated timetable to enable faster patient access to this medicine.9 This was also supported though the European Medicines Agency’s (EMA) PRIority MEdicines (PRIME) scheme, which provides early and enhanced scientific and regulatory support to medicines that have a particular potential to address patients’ unmet medical needs.10

Teclistamab is currently being evaluated in several monotherapy and combination studies.7,11,12,13,14

About Multiple Myeloma

Multiple myeloma is an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.15 In multiple myeloma, cancerous plasma cells change and grow out of control.15 In Europe, more than 50,900 people were diagnosed with multiple myeloma in 2020, and more than 32,400 patients died.16 While some patients with multiple myeloma initially have no symptoms, others can have common symptoms of the disease which can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels or kidney failure.17