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The US Food and Drug Administration (FDA) has placed a partial clinical hold on 3 trials of the PD-1 immune checkpoint inhibitor nivolumab (Opdivo).
The trials were designed to investigate nivolumab-based combination regimens in patients with relapsed or refractory multiple myeloma (MM).
The partial clinical hold means patients currently enrolled in these 3 trials can continue treatment if they are experiencing clinical benefit. However, no new patients can be enrolled at this time.
The partial clinical hold is related to risks identified in trials studying another anti-PD-1 agent, pembrolizumab, in MM patients.
Data from the pembrolizumab trials indicate the risks outweigh the benefits when PD-1/PD-L1 treatment is given to MM patients in combination with dexamethasone and pomalidomide or lenalidomide.
In addition, there may be an unfavorable risk-benefit ratio for MM patients receiving PD-1/PD-L1 treatments alone or in other combinations.
With this in mind, the FDA placed the partial hold on the following nivolumab trials:
- CheckMate-602: A randomized, phase 3 trial of combinations of nivolumab, elotuzumab, pomalidomide, and dexamethasone in relapsed and refractory MM
- CheckMate-039: A phase 1 study intended to establish the tolerability of nivolumab and the combination of nivolumab and daratumumab, with or without pomalidomide and dexamethasone, in patients with relapsed or refractory MM
- CA204142: A phase 2 study of elotuzumab in combination with pomalidomide and low-dose dexamethasone, and in combination with nivolumab, in patients with MM who relapsed after or were refractory to prior treatment with lenalidomide.
Other studies of nivolumab will continue as planned.
Bristol-Myers Squibb, the company developing and marketing nivolumab, said it remains steadfast in its commitment to improve outcomes for MM patients and will work closely with the FDA to address concerns.
Nivolumab is currently FDA-approved to treat:
- Adults with classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplant and brentuximab vedotin or after 3 or more lines of therapy, including autologous transplant
- Patients with previously treated metastatic non-small cell lung cancer
- Metastatic melanoma patients
- Advanced renal cell carcinoma patients who received prior anti-angiogenic therapy
- Patients with recurrent or metastatic squamous cell carcinoma of the head and neck on or after platinum-based therapy
- Patients with previously treated locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-based chemotherapy
- Patients (≥12 years) with microsatellite instability high or mismatch repair-deficient metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.
The US Food and Drug Administration (FDA) has placed a partial clinical hold on 3 trials of the PD-1 immune checkpoint inhibitor nivolumab (Opdivo).
The trials were designed to investigate nivolumab-based combination regimens in patients with relapsed or refractory multiple myeloma (MM).
The partial clinical hold means patients currently enrolled in these 3 trials can continue treatment if they are experiencing clinical benefit. However, no new patients can be enrolled at this time.
The partial clinical hold is related to risks identified in trials studying another anti-PD-1 agent, pembrolizumab, in MM patients.
Data from the pembrolizumab trials indicate the risks outweigh the benefits when PD-1/PD-L1 treatment is given to MM patients in combination with dexamethasone and pomalidomide or lenalidomide.
In addition, there may be an unfavorable risk-benefit ratio for MM patients receiving PD-1/PD-L1 treatments alone or in other combinations.
With this in mind, the FDA placed the partial hold on the following nivolumab trials:
- CheckMate-602: A randomized, phase 3 trial of combinations of nivolumab, elotuzumab, pomalidomide, and dexamethasone in relapsed and refractory MM
- CheckMate-039: A phase 1 study intended to establish the tolerability of nivolumab and the combination of nivolumab and daratumumab, with or without pomalidomide and dexamethasone, in patients with relapsed or refractory MM
- CA204142: A phase 2 study of elotuzumab in combination with pomalidomide and low-dose dexamethasone, and in combination with nivolumab, in patients with MM who relapsed after or were refractory to prior treatment with lenalidomide.
Other studies of nivolumab will continue as planned.
Bristol-Myers Squibb, the company developing and marketing nivolumab, said it remains steadfast in its commitment to improve outcomes for MM patients and will work closely with the FDA to address concerns.
Nivolumab is currently FDA-approved to treat:
- Adults with classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplant and brentuximab vedotin or after 3 or more lines of therapy, including autologous transplant
- Patients with previously treated metastatic non-small cell lung cancer
- Metastatic melanoma patients
- Advanced renal cell carcinoma patients who received prior anti-angiogenic therapy
- Patients with recurrent or metastatic squamous cell carcinoma of the head and neck on or after platinum-based therapy
- Patients with previously treated locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-based chemotherapy
- Patients (≥12 years) with microsatellite instability high or mismatch repair-deficient metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.
The US Food and Drug Administration (FDA) has placed a partial clinical hold on 3 trials of the PD-1 immune checkpoint inhibitor nivolumab (Opdivo).
The trials were designed to investigate nivolumab-based combination regimens in patients with relapsed or refractory multiple myeloma (MM).
The partial clinical hold means patients currently enrolled in these 3 trials can continue treatment if they are experiencing clinical benefit. However, no new patients can be enrolled at this time.
The partial clinical hold is related to risks identified in trials studying another anti-PD-1 agent, pembrolizumab, in MM patients.
Data from the pembrolizumab trials indicate the risks outweigh the benefits when PD-1/PD-L1 treatment is given to MM patients in combination with dexamethasone and pomalidomide or lenalidomide.
In addition, there may be an unfavorable risk-benefit ratio for MM patients receiving PD-1/PD-L1 treatments alone or in other combinations.
With this in mind, the FDA placed the partial hold on the following nivolumab trials:
- CheckMate-602: A randomized, phase 3 trial of combinations of nivolumab, elotuzumab, pomalidomide, and dexamethasone in relapsed and refractory MM
- CheckMate-039: A phase 1 study intended to establish the tolerability of nivolumab and the combination of nivolumab and daratumumab, with or without pomalidomide and dexamethasone, in patients with relapsed or refractory MM
- CA204142: A phase 2 study of elotuzumab in combination with pomalidomide and low-dose dexamethasone, and in combination with nivolumab, in patients with MM who relapsed after or were refractory to prior treatment with lenalidomide.
Other studies of nivolumab will continue as planned.
Bristol-Myers Squibb, the company developing and marketing nivolumab, said it remains steadfast in its commitment to improve outcomes for MM patients and will work closely with the FDA to address concerns.
Nivolumab is currently FDA-approved to treat:
- Adults with classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplant and brentuximab vedotin or after 3 or more lines of therapy, including autologous transplant
- Patients with previously treated metastatic non-small cell lung cancer
- Metastatic melanoma patients
- Advanced renal cell carcinoma patients who received prior anti-angiogenic therapy
- Patients with recurrent or metastatic squamous cell carcinoma of the head and neck on or after platinum-based therapy
- Patients with previously treated locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-based chemotherapy
- Patients (≥12 years) with microsatellite instability high or mismatch repair-deficient metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.