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Abstract

Abstract: P344

Type: Poster Presentation

Presentation during EHA22: On Friday, June 23, 2017 from 17:15 - 18:45

Location: Poster area (Hall 7)

Background
Treatment options are needed for patients with RRMM. PD-L1 is expressed in patients with multiple myeloma, and blocking the programmed death 1 (PD-1) pathway may provide antitumor activity. Pembrolizumab is a humanized, high-affinity monoclonal antibody directed against PD-1 with robust antitumor activity and favorable safety in several solid and hematologic malignancies. KEYNOTE-013 (NCT01953692) is a multicohort phase 1b study of pembrolizumab monotherapy in patients with hematologic malignancies; results are reported for patients with RRMM.

Aims
To determine the safety, tolerability, and antitumor activity of pembrolizumab monotherapy in patients with RRMM.

Methods
Patients with RRMM who have failed ≥2 prior lines of therapy including a proteasome inhibitor and immunomodulatory drug (IMiD) received pembrolizumab 10 mg/kg every 2 weeks or 200 mg fixed dose every 3 weeks. Primary end points were safety, tolerability, and objective response rate (ORR) as determined by investigators, per International Myeloma Working Group 2006 criteria.

Results
At data cutoff of January 2, 2017, 30 patients were treated. The median (range) duration of follow-up was 15 (1-32) months. 28 (93%) patients discontinued the study; the most common reason was disease progression in 14 (47%) patients and clinical progression in 9 (30%) patients. 2 (7%) patients are still on treatment. Median (range) age was 70 (56-81) years. 21 (70%) patients had an ECOG performance status of 1. Patients received a median (range) of 4 (2-10) prior lines of therapy. 20 (67%) patients were lenalidomide refractory, 10 (33%) were double-refractory, 9 (30%) were triple refractory, and 1 (3%) patient was quadruple refractory. Among patients who received pembrolizumab at 10 mg/kg, the median (range) of pembrolizumab exposure was 6 (2-15) cycles; among those who received 200-mg fixed dose of pembrolizumab, the exposure was 3 (2-6) cycles. No patient experienced a response. Seventeen (57%; 95% CI, 37-75%) patients had stable disease. 13 (43%; 95% CI, 26-63%) patients had progressive disease as their best response. Treatment-related adverse events (TRAEs) occurred in 12 (40%) patients. The most common TRAE was asthenia (n = 5, 17%); arthralgia, aspartate aminotransferase increased, fatigue, hyperglycemia, hypothyroidism, myalgia, pruritus, and blurred vision occurred in 1 patient each. A grade 3 TRAE (myalgia) occurred in 1 (3%) patient. There were no grade 4 TRAEs and no deaths due to TRAEs. 1 (3%) patient had an immune-related adverse event (grade 1 pruritus).

Conclusion
The safety profile of pembrolizumab in RRMM was consistent with that observed with other cancers. Best response observed while on pembrolizumab monotherapy was stable disease. Recent results of ongoing studies, such as KEYNOTE-023 (NCT02036502), demonstrate promising efficacy of pembrolizumab in combination with IMiDs (lenalidomide) and dexamethasone in patients with RRMM.

Session topic: 14. Myeloma and other monoclonal gammopathies - Clinical

Keyword(s): Multiple Myeloma, Immunotherapy

Abstract: P344

Type: Poster Presentation

Presentation during EHA22: On Friday, June 23, 2017 from 17:15 - 18:45

Location: Poster area (Hall 7)

Background
Treatment options are needed for patients with RRMM. PD-L1 is expressed in patients with multiple myeloma, and blocking the programmed death 1 (PD-1) pathway may provide antitumor activity. Pembrolizumab is a humanized, high-affinity monoclonal antibody directed against PD-1 with robust antitumor activity and favorable safety in several solid and hematologic malignancies. KEYNOTE-013 (NCT01953692) is a multicohort phase 1b study of pembrolizumab monotherapy in patients with hematologic malignancies; results are reported for patients with RRMM.

Aims
To determine the safety, tolerability, and antitumor activity of pembrolizumab monotherapy in patients with RRMM.

Methods
Patients with RRMM who have failed ≥2 prior lines of therapy including a proteasome inhibitor and immunomodulatory drug (IMiD) received pembrolizumab 10 mg/kg every 2 weeks or 200 mg fixed dose every 3 weeks. Primary end points were safety, tolerability, and objective response rate (ORR) as determined by investigators, per International Myeloma Working Group 2006 criteria.

Results
At data cutoff of January 2, 2017, 30 patients were treated. The median (range) duration of follow-up was 15 (1-32) months. 28 (93%) patients discontinued the study; the most common reason was disease progression in 14 (47%) patients and clinical progression in 9 (30%) patients. 2 (7%) patients are still on treatment. Median (range) age was 70 (56-81) years. 21 (70%) patients had an ECOG performance status of 1. Patients received a median (range) of 4 (2-10) prior lines of therapy. 20 (67%) patients were lenalidomide refractory, 10 (33%) were double-refractory, 9 (30%) were triple refractory, and 1 (3%) patient was quadruple refractory. Among patients who received pembrolizumab at 10 mg/kg, the median (range) of pembrolizumab exposure was 6 (2-15) cycles; among those who received 200-mg fixed dose of pembrolizumab, the exposure was 3 (2-6) cycles. No patient experienced a response. Seventeen (57%; 95% CI, 37-75%) patients had stable disease. 13 (43%; 95% CI, 26-63%) patients had progressive disease as their best response. Treatment-related adverse events (TRAEs) occurred in 12 (40%) patients. The most common TRAE was asthenia (n = 5, 17%); arthralgia, aspartate aminotransferase increased, fatigue, hyperglycemia, hypothyroidism, myalgia, pruritus, and blurred vision occurred in 1 patient each. A grade 3 TRAE (myalgia) occurred in 1 (3%) patient. There were no grade 4 TRAEs and no deaths due to TRAEs. 1 (3%) patient had an immune-related adverse event (grade 1 pruritus).

Conclusion
The safety profile of pembrolizumab in RRMM was consistent with that observed with other cancers. Best response observed while on pembrolizumab monotherapy was stable disease. Recent results of ongoing studies, such as KEYNOTE-023 (NCT02036502), demonstrate promising efficacy of pembrolizumab in combination with IMiDs (lenalidomide) and dexamethasone in patients with RRMM.

Session topic: 14. Myeloma and other monoclonal gammopathies - Clinical

Keyword(s): Multiple Myeloma, Immunotherapy

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