Pomalidomide Shows Strong Activity in Relapsed/Refractory Myeloma

August 2012 Vol 5, No 5, Special Issue ASCO 2012 Payers' Perspective - Multiple Myeloma
Caroline Helwick

Chicago, IL—The novel immuno­modulatory drug (IMiD) pomalidomide showed strong activity in patients with multiple myeloma who are not responding to current therapies, said Irene Ghobrial, MD, medical staff member in the Myeloma Program of the Dana Farber Cancer Institute, and Associate Professor of Medicine, Harvard Medical School, Boston.

“As myeloma patients live longer and longer, they need new agents of therapy, and pomalidomide may be one of those,” said Dr Ghobrial, who presented the results of this phase 2 clinical trial during ASCO 2012.

“This agent is showing responses even in patients who are resistant to bortezomib or lenalidomide,” Dr Ghobrial said, noting that adding a new IMiD to the available treatment options will be especially critical for patients with relapsed/refractory disease.

Pomalidomide plus Dexamethasone
Ravi Vij, MD, Associate Professor, Department of Medicine, Oncology Division, Bone Marrow Transplanta­tion and Leukemia Section, Washing­ton University School of Medicine, St Louis, MO, presented updated results of a phase 2 clinical trial of pomalidomide in combination with low-dose dexamethasone in 221 patients resistant to lenalidomide, to bortezomib, or to both. The pomalidomide/dexamethasone combination in­duced responses in heavily pretreated patients, including patients who had received stem-cell transplantation.

The overall response rate to the pomalidomide/dexamethasone combination was 30% compared with 9% with pomalidomide alone, after a median (number) of 5 cycles and a median (time) of 2 months. Three quarters of patients achieved stable disease or better. Median progression-free survival (PFS) was 3.5 months for the whole group.

A 1-year overall survival (OS) was reached by 59% of the patients, and median OS was similar (approximately 14 months) between the 2 arms, Dr Vij reported. Patients who had relapsed after stem-cell transplantation had a median PFS of approximately 4 months. No severe cases of peripheral neuropathy were reported.

In June, a New Drug Application for pomalidomide in combination with low-dose dexamethasone was submitted to the US Food and Drug Administration.

Adding Clarithromycin to the Mix
Another phase 2 clinical trial evaluated pomalidomide in combination with clarithromycin and dexamethasone (ClaPD) in 73 heavily pretreated pa­tients with relapsed/refractory myeloma. The antibiotic clarithro­mycin has been shown to enhance the anti­myeloma activity of pomalidomide/ dexamethasone.

The overall response rate was 56%. Even among the patients whose disease was refractory to lenalidomide and to bortezomib, the response rate was 58%.

Median PFS was 7.5 months, and, at a median follow-up of 12 months, 85% of the patients were alive and 42% remained progression-free.

“Response to ClaPD is rapid, well tolerated, and sustained over 7 months in most subjects,” said Adriana C. Rossi, MS, MD, Clinical Fellow, Hematology/Oncology, Weill Cornell Medical College, New York. “These data support the clinical efficacy of pomalidomide-based regimens in relapsed/refractory myeloma.”

Related Items
FDA Approves Darzalex Combination for First-Line Treatment of Transplant-Eligible Patients with Multiple Myeloma
Web Exclusives published on September 27, 2019 in FDA Approvals, Multiple Myeloma, In the News
Elotuzumab, Lenalidomide, and Dexamethasone Combination Demonstrates High Response Rate in High-Risk Smoldering Multiple Myeloma
Chase Doyle
January/February 2019, Vol 12, Special Issue: Payers’ Perspectives in Oncology: ASH 2018 Highlights published on February 27, 2019 in Multiple Myeloma
Pomalidomide Added to the Regimen in First Relapse Extends PFS in Multiple Myeloma
Wayne Kuznar
August 2018 Vol 11, Special Issue published on August 20, 2018 in Multiple Myeloma
ASCO 2017: Multiple Myeloma Highlights
August 2017, Vol 10, Special Issue: Payers’ Perspectives in Oncology: ASCO 2017 Highlights published on August 24, 2017 in Multiple Myeloma
CAR T-Cell Immunotherapy Makes Strides in Multiple Myeloma, with Durable Remission
Wayne Kuznar
August 2017, Vol 10, Special Issue: Payers’ Perspectives in Oncology: ASCO 2017 Highlights published on August 24, 2017 in Multiple Myeloma
Last modified: July 21, 2014
  •  Association for Value-Based Cancer Care
  • Oncology Practice Management
  • Value-Based Cancer Care
  • Value-Based Care in Rheumatology
  • Rheumatology Practice Management
  • Urology Practice Management
  • Lynx CME