Kerri Fitzgerald

DocwireNews

Meletios A. Dimopoulos, MD, of the National and Kapodistrian University of Athens in Greece, discusses outcomes from the phase III APOLLO, presented at the ASH Annual Meeting &amp; Exposition, that assessed the efficacy of the addition of daratumumab to pomalidomide and dexamethasone in relapsed/refractory multiple myeloma.DocWire News: Can you give an overview of the study design of the phase III APOLLO study and highlight its findings?Dr. Dimopoulos: This is a prospective, randomized trial for patients with relapsed and/or refractory myeloma who have received at least one line of prior therapy, which included bortezomib and lenalidomide. A total of 300 patients were randomized on a 1:1 basis to receive either pomalidomide and low-dose dexamethasone or the same combination with the addition of subcutaneous daratumumab. In both arms, treatment was continued until there was evidence of disease progression or unacceptable toxicity. Patient and disease characteristics were well-balanced, with a median age of 67 years. Median prior lines of therapy was two, and 10% of the patients had received one prior line of therapy. A total of 65% of the patients were refractory to both lenalidomide and bortezomib. The main endpoint of the study was progression-free survival (PFS). This endpoint was met, with an improvement of PFS in favor of the triplet [therapy], with a median PFS of 12.4 months versus 6.9 months for pomalidomide and low-dose dexamethasone [alone].The hazard ratio was 0.63, indicating that there was a 37% decrease of progression or death in favor of the combination of subcutaneous daratumumab with pomalidomide and low-dose dexamethasone. PFS benefit was seen across all pre-specified subgroups, and more specifically for patients refractory to lenalidomide, the hazard ratio was 0.36.Response rate was also improved with administration of subcutaneous daratumumab with pomalidomide and low-dose dexamethasone, with response rate of 69% versus 46% in the control arm (doublet arm). Minimal residual disease negativity was 9% versus 2%, respectively.The toxicity profile was consistent with the known safety profile of subcutaneous daratumumab and pomalidomide and low-dose dexamethasone alone. The side effects were equally distributed among the two groups, with the exception of more leukopenia, febrile neutropenia, and pneumonias occurring in the combination of pomalidomide-dexamethasone with subcutaneous daratumumab. The side effects leading to treatment discontinuation was low in both arms. Infusion-related reactions occurred in only 5% of the patients receiving the subcutaneous daratumumab combination, and it was grade 1 or two.DocWire News: Daratumumab plus pomalidomide and dexamethasone is FDA-approved for patients with relapsed/refractory multiple myeloma who have received two or more lines of therapy. The APOLLO study assessed this regimen in patients who have received one or more lines of therapy. Do you think the study results indicate this regimen could be used earlier in more patients?Dr. Dimopoulos: Yeah, absolutely. I think that this is a suitable combination for patients who, for example, receive a frontline treatment with bortezomib, lenalidomide, and dexamethasone, which is a frequently used regimen in the United States. Every study provides evidence that this combination could be used as a second-line treatment. Furthermore, these prospective, randomized trial data will be available to other regulatory authorities and we expect that this combination will be approved by European Medicines Agency as well.DocWire News: How could the triplet regimen of daratumumab, pomalidomide, and dexamethasone being available earlier for patients impact treatment and outcomes in this patient population?Dr. Dimopoulos: We have a combination which appears to be effective when given later in the course of the disease. We have data about the patients who have received only one prior line of therapy, and I believe that this combination may be better tolerated and more effective when used as soon as resistance to key treatment drugs, such as bortezomib and lenalidomide, is observed.

Jordana Jampel

Positive Preliminary Results From Phase 1 Trial of Dopaminergic Neuron Graft for Parkinson’s Disease

Dementia

Bradley Warady, MD

Joel M. Topf, MD, FACP

2025 Hume Award Winner Is Dedicated to Children’s Care

NKF Spring Clinical Meetings 2025

Distant Brain Metastases in Cutaneous Melanoma May Be Mitigated With Multiple Pathway Inhibitors

Melanoma

Latest News

ASH 2020: Could the Combo Daratumumab, Pomalidomide, and Dexamethasone Be Used in an Earlier Line of Therapy?

ASH Annual Meeting 2020

Meletios A. Dimopoulos, MD, of the National and Kapodistrian University of Athens in Greece, discusses outcomes from the phase III APOLLO, presented at the ASH Annual Meeting ...

ASH 2020: Could the Combo Daratumumab, Pomalidomide, and Dexamethasone Be Used in an Earlier Line of

About Us

Editorial Policy

Advertising

Contact Us

eNewsletters

Contribute

Career Center

MashupMD

Blood Cancers Today

Cancer Nursing Today

GU Oncology Now

Urban Health Today

Bile Duct Cancer

Colorectal Cancer

Gastroesophageal Cancer

Gastric Cancer

GEP-NETs

GIST

Liver Cancer

Pancreatic Cancer

GI Oncology Now

Anemia

Deep Vein Thrombosis

Essential Thrombocythemia

Hemophilia

Immune Thrombocytopenic Purpura

Myelodysplastic Syndromes

Myelofibrosis

Myeloproliferative Neoplasms

Polycythemia Vera

Pulmonary Embolism

Sickle Cell Disease

Thrombocytopenia

Thrombophilia

Thrombosis

Thrombotic Thrombocytopenic Purpura

Venous Thromboembolism

von Willebrand Disease

Heme Today

Acute Kidney Injury

ADPKD

Anemia and Kidney Disease

Chronic Kidney Disease

COVID-19 and Kidney Disease

Diabetes and Hypertension

End-Stage Renal Disease

Gout

Hyperkalemia

IgAN

Kidney Transplantation

Metabolic Acidosis

Nephrology Times

HER2 Breast Cancer

HR Breast Cancer

Triple-Negative Breast Cancer

Genetics & Breast Cancer

Breast Cancers Today

Atherosclerotic Disease

Atrial Fibrillation

Heart Failure

Hypertension

Interventional Cardiology

Lipid Management

Practice Tips With Dr. Lichaa

Preventive Cardiology

Stroke

Cardiology

Breast Cancer

Gynecologic Cancer

Head and Neck Cancer

Skin Cancer

Oncology

Sleep

Urology

Diabetes

Ophthalmology

— Demodex Blepharitis

Neurology

Rheumatology

Gastroenterology

Pulmonology

Infectious Diseases

— HIV

Health and Wellness

Lupus

Future of Medicine

Orthopedics

Pharmacology

Career News

More

Conferences

CardioNerds

The Sleep Source With Dr. Morse

Rheumatology Rounds With Dr. Maheswaranathan

Partners

Expert Interviews

Subscribe