MULTIPLE MYELOMA

A Biologics License Application was submitted to the FDA seeking approval for a new subcutaneous formulation of daratumumab in select patients with multiple myeloma.

Phillipe Moreau, MD, discusses the results from the randomized, open-label, multicenter phase III CASSIOPEIA trial. The results of the trial led to a priority review designation from the FDA for the combination of daratumumab plus bortezomib, thalidomide, and dexamethasone for patients with treatment-naïve multiple myeloma who are candidates for autologous stem cell transplant.

The FDA has accepted and is reviewing a Biologics License Application (BLA) for isatuximab as a potential treatment for patients with relapsed or refractory multiple myeloma. A target action date of April 30, 2020 has been set by the agency.¹<br /> &nbsp;

The 4-drug regimen of daratumumab in combination with bortezomib, lenalidomide, and dexamethasone induced a high percentage of stringent complete responses compared with VRd alone in patients with newly diagnosed multiple myeloma who are eligible for high-dose chemotherapy and an autologous stem cell transplantation, according to topline results of the GRIFFIN trial. This met the primary endpoint of the phase II trial.

Selinexor has received an accelerated approval from the FDA for use in combination with&nbsp;dexamethasone for the treatment of adult patients with relapsed/refractory multiple myeloma who have received &ge;4 prior therapies and whose disease is refractory to &ge;2 proteasome inhibitors, &ge;2 immunomodulatory agents, and an anti-CD38 monoclonal antibody.

In June 2019, the FDA approved a number of agents many fields, including diffuse large B-cell lymphoma, head and neck squamous cell carcinoma, small cell lung cancer, gastroenteropancreatic neuroendocrine tumors, and multiple myeloma. The FDA also approved the fifth biosimilar for trastuzumab and another biosimilar for&nbsp;bevacizumab across several indications.

The frontline combination of daratumumab with lenalidomide and dexamethasone has been approved by the FDA&nbsp;for the treatment of patients with multiple myeloma who are ineligible for autologous stem cell transplantation.

The FDA has lifted a partial clinical hold placed on the phase III CANOVA trial, which is investigating the combination of venetoclax and dexamethasone in comparison with pomalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma and a transformation (11;14) abnormality.

The combination of venetoclax and bortezomib lead to an increased number of deaths by infection in patients with multiple myeloma in the phase III BELLINI trial, according to data presented at the 2019 EHA Congress. Deaths increased in spite of promising responses data and a high progression-free survival rate.

Andrew L. Pecora, MD, FACP, CPE, discusses the biggest areas of research in the field of multiple myeloma. Pecora says that there has been a surprising number of advances in the field, with current research mostly focused on 1 of 3 areas.

In an interview with&nbsp;<em>Targeted Oncology,&nbsp;</em>Phillipe Moreau, MD, discussed the findings from the phase III CASSIOPEIA trial and the potential role for daratumumab in patients with newly diagnosed multiple myeloma in combination with standard-of-care VTd before SCT.

<em>Targeted Oncology</em>&nbsp;spoke with experts in attendance at the 2019 ASCO Annual Meeting to review what they believed were some of the biggest takeaways from this year&#39;s presentation across the fields of lung cancer, breast cancer, GI cancers, genitourinary cancers, melanoma, and multiple myeloma.

Progression-free survival was significantly improved with the triplet combination of&nbsp;isatuximab,&nbsp;pomalidomide, and low-dose dexamethasone compared with pomalidomide and dexamethasone alone in patients with&nbsp;relapsed/refractory multiple myeloma, according to findings from the phase III ICARIA-MM trial presented at the 2019 ASCO Annual Meeting.<br /> &nbsp;

A subcutaneous formulation of daratumumab showed similar efficacy to the original intravenous formulation of daratumumab in the phase III COLUMBA trial of patients with relapsed/refractory multiple myeloma. The subcutaenous flat-dose of daratumumab also showed a reduction in the treatment burden, according to results presented at the 2019 ASCO Annual Meeting.

According to&nbsp;a study authors performed to call attention to the need to address socioeconomic disparities that influence treatment outcomes, higher incomes and having private insurance were associated with a significantly greater probability of survival for patients with multiple myeloma.

The FDA has granted a priority review designation to a supplemental Biologics License Application (sBLA) for daratumumab (Darzalex) in combination with bortezomib (Velcade), thalidomide (Thalomid), and dexamethasone for the treatment of newly diagnosed patients with multiple myeloma who are candidates for autologous stem cell transplant.

Multiple Myeloma

Noopur Raje, MD, discusses the current treatment options for patients diagnosed with multiple myeloma. At this time, a number of FDA-approved drugs and different combinations are available.

Lenalidomide induced a 72% reduction in the risk of progression to symptomatic disease in patients with smoldering multiple myeloma at 3 years, according to data from the ECOG E3A06 study, to be presented during the 2019 ASCO Annual Meeting.

Novel radiotherapeutic CLR 131 has been granted a fast track designation from the FDA as a fourth-line or later treatment for patients with relapsed or refractory multiple myeloma.

The FDA has granted P-BCMA-101 with an orphan drug designation for the treatment of patients with relapsed and/or refractory multiple myeloma.