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Seeking Ways to Extend Progression-Free Survival for Patients with Multiple Myeloma

Sponsored Content by Janssen Pharmaceutical Companies of Johnson & Johnson
Published: Tuesday, Mar 05, 2019

Nizar J. Bahlis, MD
Nizar J. Bahlis, M.D.
In 2019, more than 30,000 Americans are expected to be diagnosed with multiple myeloma, the second most common blood cancer.1,2 The introduction of new medicines, including proteasome inhibitors and immunomodulatory agents over the last decade, has led to significant progress for patients.3 However, despite the advancements in treatment, multiple myeloma remains an incurable disease.3 Patients are likely to relapse and become refractory to treatment over time, and physicians seek new treatment options.3,4

One of the options is DARZALEX® (daratumumab), a monoclonal antibody that targets CD38.5 CD38 is expressed on hematopoietic cells, other cell types and tissues, and is overexpressed on multiple myeloma cells.5 DARZALEX inhibits tumor cell growth through direct on-tumor and immunomodulatory mechanisms of actions.5 DARZALEX may also have an effect on normal cells.5 DARZALEX is approved by the U.S. Food and Drug Administration (FDA) in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy.5 The approval of DARZALEX in combination with lenalidomide and dexamethasone (D-Rd) was based on the randomized, Phase 3 POLLUX clinical trial of 569 patients with multiple myeloma who had at least one prior line of therapy.5 The D-Rd arm (286 patients) received 25 mg of lenalidomide on days 1-21 of each 28-day Cycle, 40 mg of dexamethasone per week and 16 mg of daratumumab weekly for Cycles 1-2, every 2 weeks for Cycles 3-6 and then every 4 weeks until disease progression.5

The results showed:
  • At a median follow-up of 13.5 months, D-Rd reduced the risk of disease progression or death by 63% compared to patients in the control arm (Rd) who did not receive DARZALEX.5 The median progression-free survival (PFS) for D-Rd had not yet been reached, compared to 18.4 months with Rd alone.5
  • A significantly higher overall response rate (ORR) (91% vs 75%, respectively) was observed with the DARZALEX combination compared to Rd alone. D-Rd resulted in deeper responses, as 42.3% of patients achieved complete response (CR) or better compared to 18.8% of those in the Rd arm.5
  • The most frequent adverse reactions (ARs) (>20%) with D-Rd were infusion reactions, diarrhea, nausea, fatigue, pyrexia, upper respiratory tract infection, muscle spasms, cough and dyspnea.5 Serious ARs with at least a 2% greater incidence in the D-Rd arm compared to the Rd arm were pneumonia (12% vs 10%), upper respiratory tract infection (7% vs 4%), influenza and pyrexia (3% vs 1% for each), respectively.5 Grade 3/4 treatment-emergent adverse events (TEAEs) occurred in 28% of patients in the D-Rd arm vs 23% in the Rd arm.5 Discontinuation rates due to ARs with D-Rd were similar to Rd alone (7% vs 8%, respectively).5
More recently, important longer-term follow-up data have become available from the POLLUX study. In fact, data presented at the American Society of Hematology (ASH) Annual Meeting in December 2018 continued to show positive results for DARZALEX when added to a standard of care of lenalidomide and dexamethasone.6

These follow-up data showed that after a median follow-up of 44.3 months in the intent-to-treat (ITT) patient population treated with D-Rd, these patients had a median PFS of 3.7 years (44.5 months) compared with 1.5 years (17.5 months) among patients who received Rd alone (HR 0.44; 95% confidence interval [CI]: 0.35-0.55).6 The post-hoc analysis was not adjusted for multiplicity.6

“We’ve come a long way in the treatment of multiple myeloma in the past decade. But, for those individuals battling this disease, there’s still much more to be done,” said Nizar Bahlis, M.D., Associate Professor, Arnie Charbonneau Cancer Institute, University of Calgary, and Principal Investigator of the POLLUX study sponsored by Janssen Research & Development, LLC. “The addition of DARZALEX to this current standard of care may offer an important option and a way to attack this disease.”

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