Emily Menendez

Cancer Nursing Today nonprod

<p>Two new bispecific antibody treatments for relapsed or refractory multiple myeloma (RRMM) will soon be available to use for patients. Janssen&rsquo;s Tecvayli (teclistamab-cqyv) has been granted accelerated approval by the Food and Drug Administration (FDA), while Pfizer&rsquo;s elranatamab has been designated as a breakthrough therapy that will put the drug on a fast track for approval.<p>Bispecific antibodies work by attaching to T cells to enable them to attack cancer cells. They can work as more readily available alternatives to CAR-T treatments, or can act as a bridge to them.</p><h2>Teclistamab-cqyv for Multiple Myeloma</h2><p>Janssen&rsquo;s Tecvayli, also known as teclistamab-cqyv, is a bispecific antibody given subcutaneously that was granted <a href="https://www.jnj.com/u-s-fda-approves-tecvayli-teclistamab-cqyv-the-first-bispecific-t-cell-engager-antibody-for-the-treatment-of-patients-with-relapsed-or-refractory-multiple-myeloma" target="_blank" rel="noopener">accelerated approval</a> on October 25, 2022. The drug has been approved for use in RRMM patients who have previously received 4 or more prior lines of therapy that included a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody.</p><p>The Phase 2 <a href="https://pubmed.ncbi.nlm.nih.gov/34388396/" target="_blank" rel="noopener">MajesTEC-1 trial</a> studied the effects of teclistamab in multiple myeloma patients who had previously received a median of 5 prior lines of therapy. A total of 157 patients were enrolled and received at least 1 dose of teclistamab, with 40 patients receiving a second phase 2 dose. The patients who received a phase 2 dose achieved a 65% overall response rate, and 58% of patients received a &ldquo;very good&rdquo; partial response or better.</p><p>The promising results of the MajesTEC-1 trial aided in teclistamab-cqyv&rsquo;s accelerated approval by the FDA.</p><h2>Elranatamab for Multiple Myeloma</h2><p>Pfizer&rsquo;s bispecific antibody elranatamab received its <a href="https://www.pfizer.com/news/press-release/press-release-detail/pfizers-elranatamab-granted-fda-breakthrough-therapy" target="_blank" rel="noopener">breakthrough status</a> on November 3, 2022, which will speed up the drug&rsquo;s approval process and may not require the drug to be tested in large clinical trials. Similar to teclistamab-cqyv, elranatamab is also given subcutaneously.</p><p>A press release from Pfizer stated that elranatamab works by binding to B-cell maturation antigens (BCMA), &ldquo;which [are] highly expressed on the surface of multiple myeloma cells, and the CD3 receptor found on the surface of T-cells, bridging them together and activating the T-cells to kill the myeloma cells. The binding affinity of elranatamab for BCMA and CD3 has been engineered to elicit potent T-cell mediated anti-myeloma activity.&rdquo;</p><p>Positive results from the Phase 2 <a href="https://clinicaltrials.gov/ct2/show/NCT04649359" target="_blank" rel="noopener">MagnetisMM-3 study</a> led to the drug&rsquo;s breakthrough designation. In the study, 94 patients were given 76 mg of elranatamab weekly with a 2-step-up priming dose regimen administered during the first week. At a median follow-up of 6.8 months, the drug was found to have a 61% overall response rate, and a 90.4% probability of maintaining a response for longer than 6 months. The dosage of 76 mg is also suggested to have a manageable safety profile in patients with triple-class refractory multiple myeloma.</p><p>Along with its breakthrough therapy designation, elranatamab has also been granted orphan drug designation by the FDA and the European Medicines Agency to treat multiple myeloma.</p></p>


New Antibody Treatments for Multiple Myeloma

Multiple Myeloma

Janssen’s Tecvayli has been granted accelerated approval by the FDA, while Pfizer’s elranatamab has been designated as a breakthrough therapy.