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Attend this session at the
2018 ASCO Annual Meeting!


Session: Hematologic Malignancies—Plasma Cell Dyscrasia

Type: Poster Session

Time: Monday June 4, 8:00 AM to 11:30 AM

Location: Hall A


Session: Hematologic Malignancies—Plasma Cell Dyscrasia

Type: Poster Discussion Session

Time: Monday June 4, 3:00 PM to 4:15 PM

Location: E450

A phase 3 randomized study of pembrolizumab (pembro) plus lenalidomide (len) and low-dose dexamethasone (Rd) versus Rd for newly diagnosed and treatment-naive multiple myeloma (MM): KEYNOTE-185.

Sub-category:
Multiple Myeloma

Category:
Hematologic Malignancies—Plasma Cell Dyscrasia

Meeting:
2018 ASCO Annual Meeting

Abstract No:
8010

Poster Board Number:
Poster Discussion Session (Board #19)

Citation:
J Clin Oncol 36, 2018 (suppl; abstr 8010)

Author(s): Saad Zafar Usmani, Fredrik Schjesvold, Albert Oriol Rocafiguera, Lionel Karlin, Robert M. Rifkin, Habte Aragaw Yimer, Richard LeBlanc, Naoki Takezako, Robert Donald McCroskey, Kenshi Suzuki, Michele Cavo, Thierry Facon, Sundar Jagannath, Sagar Lonial, Razi Ghori, Mohammed Z.H. Farooqui, Jason Liao, Patricia Marinello, Jesus San-Miguel; Levine Cancer Institute, Charlotte, NC; Oslo University Hospital, Oslo, Norway; Institut Català d’Oncologia and Institut Josep Carreras, Hospital Germans Trias i Pujol, Badalona, Spain; Centre Hospitalier Lyon-Sud, Pierre-Bénite, France; Rocky Mountain Cancer Centers, Denver, CO; Texas Oncology, Tyler, TX; CIUSSS de l'Est de L'Ile de Montreal, Montreal, QC, Canada; Disaster Medical Center, Tokyo, Japan; Northwest Medical Specialties, PLLC, Puyallup, WA; Japanese Red Cross Medical Center, Tokyo, Japan; Seràgnoli Institute of Hematology, Bologna University School of Medicine, Bologna, Italy; Hôpital Claude Huriez, Centre Hospitalier Régional Universitaire de Lille, Lillie, France; Mount Sinai Hospital, New York, NY; Winship Cancer Institute, Emory University, Atlanta, GA; Merck & Co., Inc., Kenilworth, NJ; Universidad de Navarra, Pamplona, Spain

Abstract Disclosures

Abstract:

Background: KEYNOTE-185 (NCT02579863) evaluated Rd ± pembro in patients (pts) with newly diagnosed, ASCT-ineligible MM. Methods: Pts were randomized 1:1 to pembro (200 mg Q3W) + Rd (len 25 mg [days (d) 1-21] + 40 mg dex [weekly] every 28d) vs Rd until progression (PD), unacceptable toxicity, or withdrawal. Randomization stratified by age ( < 75 vs ≥75 y), and disease stage (ISS I or II vs III). Primary end point was PFS per 2011 IMWG; secondary end points included OS and safety. On July 3, 2017, based on interim data presented to the DMC, the FDA halted KEYNOTE-185. Results: 301/640 pts enrolled (151, pembro-Rd; 150, Rd), with median (range) age: 74 y (53-89) vs 74 y (57-91); 24 (16%) pts in pembro-Rd am vs 10 (7%) pts in Rd arm had high-risk cytogenetics. Median (range) drug exposure was 131.0 d (1-485) in pembro-Rd arm vs 162 d (1-467) in Rd arm; median 6.0 cycles. AEs with ≥5% difference between arms: constipation, pyrexia, rash, vomiting, decreased appetite, pneumonia, oral candidiasis, pruritus, hypo-/hyperthyroidism. No SAEs with ≥5% difference between arms. In pembro + Rd arm, immune-mediated AEs (≥2%): hypothyroidism (7%), hyperthyroidism (6%), colitis (2%), and skin reactions (13%). 19 (13%) pts died in the pembro-Rd arm (6 from PD, 13 from AEs); 5/19 deaths were high risk. 9 (6%) pts died in the Rd arm (1 from PD, 8 from AE); 0/9 were high-risk. 6 (4%) treatment related deaths occurred; 4 (3%) [1 cardiac arrest, 1 pneumonia; 1 myocarditis, 1 cardiac failure]) were related to pembro. Median duration of follow-up was 6.4 mo vs 6.9 mo. Median TTP was not reached in either arm. Median PFS was not reached in either arm; HR, 1.22 (95% CI, 0.67-2.22); P= 0.75. Median OS was not reached in either arm; HR, 2.06 (95% CI, 0.93-4.55); P= 0.97. A retrospective random forest analysis and a subsequent multivariable Cox regression analysis led to no conclusive results due to the small number of death events ( < 10%) at time of analysis. Conclusions: Benefit-risk profile for combination of pembro-Rd is unfavorable for newly diagnosed MM. Evaluation of T-cell subsets and cytokines along with long-term safety and survival follow-up is ongoing. Clinical trial information: NCT02579863

 
Other Abstracts in this Sub-Category:

 

1. Once-weekly vs twice-weekly carfilzomib (K) dosing plus dexamethasone (d) in patients with relapsed and refractory multiple myeloma (RRMM): Results of the randomized phase 3 study A.R.R.O.W.

Meeting: 2018 ASCO Annual Meeting Abstract No: 8000 First Author: Maria-Victoria Mateos
Category: Hematologic Malignancies—Plasma Cell Dyscrasia - Multiple Myeloma

 

2. Pomalidomide (POM), bortezomib, and low‐dose dexamethasone (PVd) vs bortezomib and low-dose dexamethasone (Vd) in lenalidomide (LEN)-exposed patients (pts) with relapsed or refractory multiple myeloma (RRMM): Phase 3 OPTIMISMM trial.

Meeting: 2018 ASCO Annual Meeting Abstract No: 8001 First Author: Paul G. Richardson
Category: Hematologic Malignancies—Plasma Cell Dyscrasia - Multiple Myeloma

 

3. Daratumumab (DARA) in combination with carfilzomib and dexamethasone (D-Kd) in lenalidomide (Len)-refractory patients (Pts) with relapsed multiple myeloma (MM): Subgroup analysis of MMY1001.

Meeting: 2018 ASCO Annual Meeting Abstract No: 8002 First Author: Ajai Chari
Category: Hematologic Malignancies—Plasma Cell Dyscrasia - Multiple Myeloma

 

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