Currently Viewing:
Evidence-Based Oncology July 2017
Currently Reading
Daratumumab With Standard Regimen Improves PFS, ORR Independent of Cytogenetic Risk in Multiple Myeloma
Surabhi Dangi-Garimella, PhD
Daratumumab-Based Combination Effective in Relapsed/Refractory Multiple Myeloma, Short PFS in Heavily Pretreated Patients
Surabhi Dangi-Garimella, PhD
Patient Selection Vital in Ensuring Improved Response to PD-1, PD-L1 Inhibitors in NSCLC
Surabhi Dangi-Garimella, PhD
An Early Stage Safety, Efficacy Study for Atezolizumab Plus Daratumumab in Advanced NSCLC
Surabhi Dangi-Garimella, PhD
LDH Levels Could Predict irAEs Associated With Checkpoint Inhibition and Radiotherapy in Lung Cancer
Surabhi Dangi-Garimella, PhD
Alectinib May Be a New Standard of Care for Treatment-Naïve ALK-Positive NSCLC
AJMC Staff
Dacomitinib a New First-Line Option for Advanced EGFR MutationŚPositive NSCLC
AJMC Staff
Androgen Deprivation, With or Without Radiotherapy, New Standard of Care in High-Risk Prostate Cancer
AJMC Staff
Trabectedin and Lurbinectedin Effective in BRCA2-Associated Metastatic Breast Cancer
AJMC Staff
HPV Vaccination May Lower Prevalence of Oropharyngeal Cancers in Young Adults
Surabhi Dangi-Garimella, PhD
Physical Activity, Healthy Diet Improve Survival in Colorectal Cancer: Study at ASCO
Surabhi Dangi-Garimella, PhD
Three Months of Oxaliplatin-Based Adjuvant Therapy Noninferior to 6 Months in Stage III Colon Cancer
AJMC Staff
Fas Biomarker Can Predict Response to Second-Line Therapy for Advanced Soft Tissue Sarcoma
AJMC Staff
Nivolumab, Alone or With Ipilimumab, Met the Disease Control Rate in Malignant Pleural Mesothelioma
AJMC Staff
Ibrutinib vs No Consolidation Are Being Compared Following Autologous HSCT in IRONCLAD Trial
AJMC Staff
Web-Based Patient Reporting of Symptoms Shown to Improve Survival in Patients With Metastatic Solid Tumors
AJMC Staff
Physician, Regulatory, and Payer Perspectives on the Value of Real-World Data
Surabhi Dangi-Garimella, PhD
Do We Have Adequate Surveillance in Cancer Care?
Surabhi Dangi-Garimella, PhD
MACRA 2.0 and Beyond: Preparing Your Practice to Meet the Quality and Reporting Challenges
Surabhi Dangi-Garimella, PhD
ASCO Study Finds Shift in Diagnosis Stage for Several Cancers Following ACA Implementation
Surabhi Dangi-Garimella, PhD
Switching Study Reports Equivalence Between Filgrastim, Biosimilar in Breast Cancer
Surabhi Dangi-Garimella, PhD
Research Demonstrates Efficacy and Safety of Trastuzumab Biosimilar SB3
Kelly Davio
CT-P6, a Trastuzumab Biosimilar, Shares the Safety and Efficacy Profile of Its Reference
Kelly Davio
Can the 4 Ps Devise Interventions to Reduce the Financial Toxicity of Cancer?
Surabhi Dangi-Garimella, PhD
Adjuvant Chemotherapy Reduces Cost, Improves Survival in NSCLC Post-Surgery
Surabhi Dangi-Garimella, PhD
Brazilian Study Queries: Is NGS Cost-Effective in Advanced Lung Cancer?
Surabhi Dangi-Garimella, PhD
SEER-Medicare Database Analysis Notes Higher Resource Utilization Among Patients With Neuroendocrine Tumors
Surabhi Dangi-Garimella, PhD

Daratumumab With Standard Regimen Improves PFS, ORR Independent of Cytogenetic Risk in Multiple Myeloma

Surabhi Dangi-Garimella, PhD
Updated trial results at the 2017 Annual Meeting of the American Society of Clinical Oncology showed the combinations of daratumumab with either lenalidomide and dexamethasone or bortezomib and dexamethasone prolonged progression-free survival for patients with relapsed refractory multiple myeloma.
IN AUGUST 2016, daratumumab (Darzalex) was granted breakthrough designation status as second-line treatment for use in combination with either lenalidomide (Revlimid) and dexamethasone (DRd regimen, POLLUX trial) or bortezomib (Velcade) and dexamethasone (DVd regimen, CASTOR trial) for patients with relapsed refractory multiple myeloma (RRMM) who have received at least 1 prior therapy.1 Updated trial results at the 2017 Annual Meeting of the American Society of Clinical Oncology2 showed the combinations prolonged progression-free survival (PFS) and improved the depth of response, independent of the patients’ cytogenetic risk.

Daratumumab is a human monoclonal antibody that targets CD38, a receptor overexpressed in multiple myeloma, resulting in complement-dependent cytotoxicity, antibody-dependent cell-mediated cytotoxicity, and antibody-dependent cellular phagocytosis. The authors examined their efficacy in patients with RRMM with standard or high cytogenetic risk status.

Bone marrow aspirates for patients who participated in the open-label, multicenter, active-controlled, randomized POLLUX and CASTOR studies were collected at screening and assessed via next-generation sequencing (NGS). Patients with high-risk cytogenetics included those who had at least 1 of the following translocations or deletions: t(4;14), t(14;16), or del17p. Patients at standard risk were negative for these abnormalities.

While 311 patient samples were analyzed via NGS from the POLLUX trial, 353 were from the CASTOR trial. At a median follow-up of 25.4 months, 65% of patients receiving DRd in the intention-to-treat population (POLLUX) had a median PFS of 24 months, compared with 41% of the control Revlimid-treated (Rd) population who had a median PFS of 17.5 months (HR, 0.41; 95% CI, 0.31-0.53; <.0001). Of patients who had received 1 prior line of therapy, median PFS was not reached in 79% of the cohort receiving DRd; it was 19.6 months in 40% receiving Rd (HR, 0.39; 95% CI, 0.26-0.58; <.0001).

At the end of a 19.4-month follow-up period (CASTOR trial), 49% of patients receiving DVd had a median PFS of 18.7 months compared with 8% patients treated with Velcade (Vd) who had a median PFS of 7.1 months (HR, 0.31; 95% CI, 0.24-0.39; P <.0001). In patients who had received 1 prior line of therapy, a median PFS was not reached in 60% of patients in the DVd arm compared with a median PFS of 7.9 months in 12% of patients in the Vd arm (HR, 0.19; 95% CI, 0.12-0.29; <.0001).

Cytogenetic risk analysis in patients in the POLLUX study showed DRd improved median PFS to 22.6 months in the high-risk patient population compared with 18.2 months in the Rd arm (HR, 0.53; 95% CI, 0.25 to 1.13; P = .0021). Median PFS was not reached in the standard-risk patients treated with DRd compared with 18.5 months in those receiving Rd (HR, 0.30; 95% CI, 0.20-0.47; P <.0001). Median PFS for high-risk patients in the CASTOR study was 11.2 months in the DVd arm and 7.2 months in the Vd arm (HR, 0.45; 95% CI, 0.25-0.80; P = .0053). In standard-risk patients, daratumumab improved median PFS to 19.6 months, against 7.9 months with Vd (HR, 0.26; 95% CI, 0.18-0.37; <.0001).

The authors concluded that daratumumab included in standard-of-care regimens in RRMM prolongs PFS and improves the depth of response regardless of cytogenetic risk. Longer-term survival results are awaited for both trials.
REFERENCES

1. Dangi-Garimella S. Breakthrough for daratumumab for use as second-line treatment with standard of care in multiple myeloma. The American Journal of Managed Care® website. www.ajmc.com/journals/evidence-based-oncology/2016/august-2016/breakthrough-for-daratumumab-for-use-as-second-line-treatment-with-standard-of-care-inmultiple-myeloma. Published August 19, 2016. Accessed June 5, 2017.

2. Weisel KC, Miguel JS, Cook G, et al. Efficacy of daratumumab in combination with lenalidomide plus dexamethasone (DRd) or bortezomib plus dexamethasone (DVd) in relapsed or refractory multiple myeloma (RRMM) based on cytogenetic risk status. J Clin Oncol. 2017;35(suppl; abst 8006).
PDF
 
Copyright AJMC 2006-2017 Clinical Care Targeted Communications Group, LLC. All Rights Reserved.
x
Welcome the the new and improved AJMC.com, the premier managed market network. Tell us about yourself so that we can serve you better.
Sign Up
×

Sign In

Not a member? Sign up now!