(Small Intestine Cancer) Is Keytruda Effective?

(Small Intestine Cancer) Is Keytruda Effective?

(Small Intestine Cancer) Is Keytruda Monotherapy Effective?

• September 6, 2019
• Read time: 2 minutes

From July 3-6, 2019, at the ESMO Gastrointestinal Cancer Congress in Barcelona, Spain, Katrina S. Pedersen presented "Efficacy and Safety of Anti-PD-1 Antibody Keytruda in a Phase 2 Clinical Trial for Small Intestinal Adenocarcinoma Patients."

This trial administered Keytruda 200mg monotherapy to small intestinal cancer patients (N=40) until disease progression or unexpected adverse events occurred. The primary endpoint was objective response rate, with secondary endpoints including progression-free survival, overall survival, and safety in a Phase 2 clinical trial. The primary endpoint success criterion was set at ≥7 of 35 patients (≥20%) achieving objective response.

The trial was undertaken because small intestinal adenocarcinoma has an incidence of 6-7 per million people, with recent increases in Western countries. Standard treatment after first-line FOLFOX/CAPOX therapy is insufficient, necessitating establishment of new standard treatment approaches. Therefore, a large-scale verification study was initiated to evaluate the efficacy of anti-PD-1 antibody Keytruda in small intestinal adenocarcinoma.

The enrolled patient characteristics were as follows: tumor locations were duodenum 60%, jejunum 25%, and ileum 15%. Microsatellite instability testing rate was 55% (N=22).

At the time trial results were announced, 32 patients had discontinued treatment for the following reasons: disease progression 78% (N=25), death 16% (N=5), adverse events 6% (N=2).

Primary endpoint objective response rate was 8%, with only 3 patients achieving partial response, failing to meet the primary endpoint criterion. Among secondary endpoints, median progression-free survival was 2.8 months. Median overall survival was 6.9 months.

Objective response rates by microsatellite instability status were: among 18 microsatellite stable patients, 6% (N=1) achieved partial response; among 2 low microsatellite instability patients, 1 had stable tumor; among 2 high microsatellite instability patients, 2 achieved partial response.

Regarding safety, Grade 3+ adverse events occurred in 58% (N=23), and Grade 4-5 adverse events in 23% (N=9).

Based on the clinical trial results, Katrina S. Pedersen concluded: Small intestinal adenocarcinoma patients treated with anti-PD-1 antibody Keytruda failed to meet the primary endpoint objective response rate, but both high microsatellite instability patients achieved partial response.

Source: https://www.oncnet.com/news/pembrolizumab-fails-achieve-goal-response-rate-patients-advanced-small-bowel-adenocarcinomaWorld Congress on Gastrointestinal Cancer 2019 #O-007)

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