TECVAYLI®
(teclistamab-cqyv)
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TECVAYLI® (teclistamab-cqyv)
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TECVAYLI - Permitted Medications in the MajesTEC-1 Study
Last Updated: 01/30/2025
SUMMARY
- MajesTEC-1 (MMY1001) is an ongoing, phase 1/2, multicohort study evaluating the safety and efficacy of TECVAYLI in patients with relapsed or refractory multiple myeloma (RRMM).1
, 2 - Cohort A (triple-class exposed) included 165 patients with RRMM who were triple-class exposed to a proteasome inhibitor (PI), an immunomodulatory drug and an anti-CD38 monoclonal antibody.1
- Cohort C included 40 patients with RRMM, previously treated with a PI, an immunomodulatory drug, and an anti-CD38 monoclonal antibody. All patients enrolled in Cohort C had prior exposure to B-cell maturation (BCMA)-targeted therapies. Janssen does not recommend the use of TECVAYLI in a manner inconsistent with the approved labeling.3
- Permitted medications in the MajesTEC-1 study protocol are summarized below.2,4
CLINICAL DATA - Majestec-1 study
MajesTEC-1 (MMY1001; clinicaltrials.gov identifiers: NCT03145181; NCT04557098) is evaluating the safety and efficacy results of TECVAYLI in patients with RRMM after ≥3 prior lines of therapy, including triple-class exposure to a proteasome inhibitor (PI), an immunomodulatory drug and an anti-CD38 monoclonal antibody.1,2
Study Design/Methods
The main objectives are as follows: Part 1 (dose escalation) to determine the recommended phase 2 dose (RP2D) for TECVAYLI; Part 2 (dose expansion) to distinguish safety and tolerability of TECVAYLI at the RP2D; Part 3 (the phase 2 component) to evaluate the efficacy of TECVAYLI at the RP2D.1,2
Patients were to receive full supportive care during the study.2,4 The following are examples of supportive therapies that were used during the study:
- Standard supportive care therapies (antiemetics, antidiarrheals, anticholinergics, antispasmodics, antipyretics, antihistamines, analgesics, antibiotics and other antimicrobials, histamine receptor [H2] antagonists or proton pump inhibitors, and other medications intended to treat symptoms or signs of disease), as clinically indicated, according to institutional standards and as deemed necessary by the investigator.2
- Bisphosphonates were permitted as part of supportive care. Patients who were on bisphosphonate therapy when they entered the study should have continued the same treatment. If clinically indicated, patients may have initiated bisphosphonate therapy as soon as possible during screening and no later than the end of Cycle 1. After Cycle 1, investigators should not have prescribed bisphosphonates to patients who had not received it before, unless it was discussed with the sponsor and there was no sign of disease progression. Use of bisphosphonates should have then continued throughout the treatment phase until disease progression was established. In case of severe adverse events such as hypercalcemia, bisphosphonates may be administered as clinically indicated, according to institutional standards, and as deemed necessary by the investigator.2
- Growth factor support, erythropoietin-stimulating agents, and transfusions were permitted to treat symptoms or signs of neutropenia, anemia or thrombocytopenia according to local standards of care; these agents were not allowed as prophylactic treatment during the dose limiting toxicity (DLT) period in Part 1. Growth factor support should have been avoided during step-up doses and first treatment dose and during cytokine release syndrome (CRS). Granulocyte colony stimulating factor (GCSF) should have been considered for Grade 3 neutropenia with infection or fever, or any Grade 4 neutropenia.2
- Prophylactic measures per institutional guidelines were recommended due to susceptibility of patients with multiple myeloma to infections. New data and guidelines led to more robust recommendations around immunoglobulin replacement. These included:
- Prophylactic immunoglobulin replacement should have been considered with initiation prior to first dose of TECVAYLI (eg, during screening). Alternatively, replacement therapy should have been initiated as early as possible during treatment regardless of immunoglobulin G (IgG) levels and regardless of presence of infections.4
- Prophylactic intravenous immunoglobulin (IVIG) use was associated with a significantly lower risk of serious infections among patients receiving TECVAYLI treatment.4
- Initiation of broad-spectrum antibiotics (eg, levofloxacin) should have been considered at study start and continued throughout the first cycle in which TECVAYLI was administered.4
- Pneumocystis carinii/jirovecii pneumonia prophylaxis.4
- Prophylaxis for herpes zoster reactivation.4
- Antiviral prophylaxis should have been initiated to prevent herpes zoster reactivation within 1 week after the start of administration of TECVAYLI and continued for 3 months following TECVAYLI treatment. Acceptable antiviral therapy included acyclovir, famciclovir, and valacyclovir.4
- It was recommended that patients receive prophylactic Coronavirus disease 2019 (COVID-19) vaccination when locally available, at the discretion of investigator judgement or institutional practice, and in compliance with the study protocol and local labels for the vaccine.4
- Empirical broad-spectrum antibiotics were recommended to be commenced while performing diagnostic tests in patients with febrile neutropenia or signs/symptoms of infection per institutional guidelines.4
- Targeted antimicrobial agents were recommended depending on clinical, radiological, and microbiological findings.4
- Corticosteroids were used as pretreatment medications before administration of TECVAYLI and are summarized in table below on MajesTEC-1 Study Protocol: Pretreatment Medications.4
| Medication | Dose | Administration | Cycles |
|---|---|---|---|
| Day of TECVAYLI Administration, Prior to TECVAYLI Administration | |||
| Glucocorticoid | dexamethasone (16 mg) | Oral or IV – administer 2 hours (±1 hour) prior to TECVAYLI | Requireda Step-up dose(s) and Cycle 1, Day 1 |
| Antihistamine | diphenhydramine (50 mg) or equivalent | Oral – administer 1 hour (±15 minutes) prior to TECVAYLI or IV – start infusion 30 minutes (±15 minutes) prior to TECVAYLI | Requiredb Step-up dose(s) and Cycle 1, Day 1 |
| Antipyretic | acetaminophen (650 mg to 1,000 mg) or equivalent | Oral or IV – administer 1 hour (±15 minutes) prior to TECVAYLI | Requiredb Step-up dose(s) and Cycle 1, Day 1 |
| H2-antagonist | ranitidine (50 mg) or equivalent | Oral or IV – administer predose per institutional practice | Optional |
| Antiemetic | ondansetron (16 mg) or equivalent | Oral or IV – administer predose per institutional practice | Optional |
| Abbreviations: CRS, cytokine release syndrome; H2, histamine receptor; IRR, infusion-related reaction; IV, intravenous.aDexamethasone should not have been administered as pretreatment medication after Cycle 1 Day 1,except in patients who experienced Grade ≥2 CRS or IRRs, pretreatment with glucocorticoid was required prior to the next dose of TECVAYLI. Administration of glucocorticoid pretreatment medication beyond this should have been discussed with the sponsor, except in patients enrolled in the exploratory cohort(s) that evaluated low-dose dexamethasone.bFor patients who experienced any grade CRS or IRRs, pretreatment with antihistamines and antipyretics were required prior to at least the next dose of TECVAYLI. Administration of pretreatment medication beyond this should have been discussed with sponsor. | |||
Literature Search
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References
| 1 | Moreau P, Garfall AL, van de Donk NWCJ, et al. Teclistamab in relapsed or refractory multiple myeloma. N Engl J Med. 2022;387(6):495-505. |
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