US FDA Approves TECVAYLI (teclistamab-cqyv), the First Bispecific T-Cell Activating Antibody for the Treatment of Patients With Relapsed/Refractory Multiple Myeloma | antibodies

US FDA Approves TECVAYLI (teclistamab-cqyv), the First Bispecific T-Cell Activating Antibody for the Treatment of Patients With Relapsed/Refractory Multiple Myeloma |  antibodies

US FDA Approves TECVAYLI (teclistamab-cqyv), the First Bispecific T-Cell Activating Antibody for the Treatment of Patients With Relapsed/Refractory Multiple Myeloma

TECVAYLI™, a ready-to-use subcutaneous therapy, is an important new drug for patients with incurable blood cancers facing limited treatment options.

HORSHAM, Pennsylvania, USA I October 25, 2022 I The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the US Food and Drug Administration (FDA) has approved TECVAYLI™ (teclistamab-cqyv) for the treatment of adult patients with relapsed or refractory multiple myeloma, which previously received four or more prior lines of therapy, which includes a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody.1 TECVAYLI™ is a first-in-class bispecific T-cell activating antibody that is administered as a subcutaneous treatment.1 This ready-to-use (or off-the-shelf) therapy uses innovative science to activate the immune system by binding to the CD3 receptor expressed on the surface of T cells and the surface-expressed B-cell maturation antigen (BCMA). of multiple myeloma cells and some healthy cells of lineage B.1

This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent on verification and description of clinical benefit in confirmatory trials.1

TECVAYLI™ is Janssen’s fourth approved treatment for multiple myeloma, further diversifying the company’s industry-leading oncology portfolio and deepening its commitment to discovering and developing therapies for this rare blood cancer.

“We are very encouraged by the FDA approval of teclistamab and Janssen’s commitment to the multiple myeloma community,” said Michael Andreini, President and CEO of the Multiple Myeloma Research Foundation. “Multiple myeloma is a life-threatening disease with considerable unmet need, and teclistamab is an important new treatment option for patients who have faced multiple relapses.”

The pivotal phase 2 MajesTEC-1 clinical trial included patients who had received a median of five prior lines of therapy (n = 110).1 An overall response rate (ORR) of 61.8 percent (95 percent confidence interval [CI]: 52.1 percent, 70.9 percent), particularly with 28.2 percent of patients achieving complete response (CR) or better (CR or strict complete response [sCR]).1 The median time to first response was 1.2 months (range 0.2 to 5.5 months). With a median follow-up of 7.4 months, the estimated duration of response rate (DOR) was 90.6% (95% CI: 80.3%, 95.7%) at six months and 66.5% (95% CI: 38.8%, 83.9%) at nine months1 The study included highly pretreated patients, with 78 percent of patients receiving four or more prior lines of therapy.1 All patients were triple-class exposed (to a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody), and 76 percent were triple-class refractory (to a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody). anti-CD38 monoclonal).1

“Today’s achievement, which marks an important addition to our diverse and growing oncology portfolio, strengthens our resolve to discover and develop much-needed cancer treatments for patients and physicians,” said Peter Lebowitz, MD, Ph.D., head of the global therapeutic area. , Oncology, Janssen Research & Development, LLC. “The approval of TECVAYLI, which demonstrated an overall response rate of more than 60 percent in highly previously treated patients, underscores our commitment to translating science into medicine as we strive to achieve our goal of one day eliminating this disease.” .

TECVAYLI™ safety information includes a boxed warning for cytokine release syndrome (CRS) and neurological toxicity, including immune effector cell-associated neurotoxicity syndrome, as well as warnings and precautions for hepatotoxicity, infections, neutropenia, hypersensitivity and other administrative and embryofetal reactions. toxicity.1 The most common adverse reactions (>20%) in the MajesTEC-1 safety population (n=165) were pyrexia, CRS, musculoskeletal pain, injection site reaction, fatigue, upper respiratory tract infection, nausea, headache, pneumonia and diarrhea. .1 The most common Grade 3 to 4 laboratory abnormalities (>20%) were decreased lymphocytes, decreased neutrophils, decreased white blood cells, decreased hemoglobin, and decreased platelets.1 TECVAYLI™ is available only through a restricted program called the TECVAYLI™ Risk Assessment and Mitigation Strategy.1 Details of important safety information are included below. TECVAYLI™ is supplied in single dose vials of 30 mg/3 mL and 153 mg/1.7 mL.1

“In the pivotal study of teclistamab, we have continued to see positive results in patients with aggressively treated refractory or relapsed multiple myeloma,” said Ajai Chari, MD, Professor of Medicine, Division of Hematology and Medical Oncology, School of Medicine. Icahn Medicine at Mount Sinai and study investigator. “As a physician and researcher, I see firsthand the human toll of this incurable disease. The approval of teclistamab, as the first bispecific antibody in relapsed/refractory multiple myeloma, is a significant step in helping many of these difficult-to-treat patients.” treat”. treat patients.”

About the MajesTEC-1 Study 1

MajesTEC-1 (NCT04557098, NCT03145181), is a Phase 1/2 single-arm, open-label, multi-cohort, multi-center dose-escalation study to evaluate the safety and efficacy of TECVAYLI™ in adults with relapsed or refractory multiple myeloma who received three or more lines of therapy. previous.

Phase 1 of the study (NCT03145181) was performed in two parts: dose escalation (Part 1) and dose expansion (Part 2). Evaluated the safety, tolerability, pharmacokinetics, and preliminary efficacy of TECVAYLI™ in adult participants with relapsed or refractory multiple myeloma. Study criteria excluded patients who had stroke, seizures, allogeneic stem cell transplant within the past six months, Eastern Cooperative Oncology Group (ECOG) performance score of 2 or more, known active CNS involvement, or signs clinical signs of meningeal involvement of multiple myeloma, or documented history of autoimmune disease, with the exception of vitiligo, type 1 diabetes, and prior autoimmune thyroiditis.

Phase 2 of the study (NCT04557098) evaluated the efficacy of TECVAYLI™ at the recommended phase 2 dose (RP2D), established at 1.5 mg/kg subcutaneously weekly, as measured by ORR. During the first week, participants received increasing doses of TECVAYLI™ subcutaneously (0.06 and 0.3 mg/kg). Subsequently, participants received weekly treatment doses of TECVAYLI™ subcutaneous 1.5 mg/kg until disease progression or unacceptable toxicity. Efficacy was established based on the ORR determined by Independent Review Committee (IRC) assessment using the 2016 International Myeloma Working Group (IMWG) criteria.

The primary endpoint was overall response rate or unacceptable toxicity. Secondary endpoints included duration of response, very good partial response, complete response, strict complete response, time to response, minimal residual disease status, progression-free survival, overall survival, safety, pharmacokinetics, immunogenicity, and patient-reported outcomes.

please read full prescription information including boxed warning for TECVAYLI™.

About multiple myeloma

Multiple myeloma is an incurable blood cancer that affects a type of white blood cells called plasma cells, which are found in the bone marrow.two In multiple myeloma, these plasma cells change, spread rapidly, and replace normal cells in the bone marrow with tumors.3 In 2022, it is estimated that more than 34,000 people will be diagnosed with multiple myeloma and more than 12,000 people will die from the disease in the US.4 While some people diagnosed with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that may include broken bones or pain, low red blood cell counts, tiredness, high calcium levels, kidney problems, or infections.5

About Pharmaceutical Companies Janssen of Johnson & Johnson

At Janssen, we are creating a future where disease is a thing of the past. We are the pharmaceutical companies of Johnson & Johnson, working tirelessly to make that future a reality for patients around the world by fighting disease with science, improving access with ingenuity, and curing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular, Metabolism and Retina; Immunology; Infectious Diseases and Vaccines; neuroscience; Oncology; and pulmonary hypertension.

Learn more at Follow us on @JanssenGlobal Y @JanssenES. Janssen Research & Development, LLC and Janssen Biotech, Inc. are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

Dr. Chari has served as a paid consultant for Janssen; he has not been paid for any media work.

FONT: Janssen

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