Best of ASCO - 2014 Annual Meeting



Publication-only abstracts (abstract number preceded by an "e"), published in conjunction with the 2017 ASCO Annual Meeting but not presented at the Meeting, can be found online only.

A study of REOLYSIN in combination with pembrolizumab and chemotherapy in patients (pts) with relapsed metastatic adenocarcinoma of the pancreas (MAP).

Pancreatic Cancer

Gastrointestinal (Noncolorectal) Cancer

2017 ASCO Annual Meeting

Abstract No:

J Clin Oncol 35, 2017 (suppl; abstr e15753)

Author(s): Devalingam Mahalingam, Christos Fountzilas, Jennifer L. Moseley, Nicole Noronha, Karol Cheetham, Adrian Dzugalo, Gerard Nuovo, Andres Gutierrez, Sukeshi Patel Arora; Cancer Therapy and Research Center at UT Health Science Center, San Antonio, TX; The University of Texas Health Sciences Center, San Antonio, TX; Institute for Drug Development, Cancer Therapy and Research Center, The University of Texas Health Science Center, San Antonio, TX; Oncolytics Biotech, Calgary, AB, Canada; OSU Comprehensive Cancer Center, Powell, OH

Abstract Disclosures


Background: REOLYSIN is an immuno-oncology-reoviral agent that induces an inflamed tumor phenotype secondary to viral infection of cancer cells. In combination with chemotherapy, it achieves 1 & 2 year-survival rates of 46% & 24% in MAP pts, respectively. Tumor analysis from pts showed reovirus protein replication, T-cell infiltration and upregulation of PD-L1. Similarly, the combination of REOLYSIN with anti-PD-1 antibody documented survival benefit in a pre-clinical model. We hypothesized that REOLYSIN in combination with chemo and pembrolizumab in pts with MAP would be clinically efficacious. Methods: A phase 2 study (NCT02620423) enrolled MAP pts who progressed after first line treatment. Pts received REOLYSIN (4.5 x 10 10TCID 50 IV, D1 & D2), plus pembrolizumab (2mg/kg IV, D8) plus either 1)5-FU (LV (200 mg/m2 /5-FU 200 mg /m2 IV bolus, 5-FU 1200mg/m2 continuous IV infusion D1) or 2) gemcitabine (1000 mg/m2 IV, D1), or 3) irinotecan (125 mg/m2 IV, D1) q3w, until disease progression/unacceptable toxicity. The primary endpoint was safety. Secondary objectives included tumor response & evaluation for reovirus replication/immune analysis. We report results of safety cohort analysis. Results: 11 pts were enrolled with REOLYSIN, pembrolizumab and gem (n = 6), 5-FU (n = 3), or iri (n = 2). Grade 1 or 2 TEAEs occurred in all pts: fever (64%), headache (55%), chills (46%), fatigue (46%), dehydration (27%), and nausea (27%). In one pt (gem arm), transient Gr 2 increased transaminases was reported on two occasions. Grade 3 or 4 TEAEs occurred in 8 pts (73%): abdominal pain, anemia, arthralgias, biliary obstruction, chills, DVT, diarrhea, fever, hyperglycemia, leukopenia, myalgias, nausea, neutropenia, pulmonary emboli, vomiting. Of the 5 efficacy evaluable pts, one had PR (6 m duration) and 2 SD (lasting 126 and 221 days). Seven died secondary to PD. On-treatment biopsy show reovirus infection in cancer cells and immune infiltrates. Conclusions: The combination therapy showed manageable safety profiles and antitumor activity in previously treated MAP pts. Further evaluation of anti-tumor activity of REOLYSIN and anti-PD-1 antibody ± chemotherapy combos is planned. Clinical trial information: NCT02620423

Other Abstracts in this Sub-Category:


1. Results of the randomized phase II portion of NRG Oncology/RTOG 0848 evaluating the addition of erlotinib to adjuvant gemcitabine for patients with resected pancreatic head adenocarcinoma.

Meeting: 2017 ASCO Annual Meeting Abstract No: 4007 First Author: Howard Safran
Category: Gastrointestinal (Noncolorectal) Cancer - Pancreatic Cancer


2. Randomized phase II study of PEGPH20 plus nab-paclitaxel/gemcitabine (PAG) vs AG in patients (Pts) with untreated, metastatic pancreatic ductal adenocarcinoma (mPDA).

Meeting: 2017 ASCO Annual Meeting Abstract No: 4008 First Author: Sunil R. Hingorani
Category: Gastrointestinal (Noncolorectal) Cancer - Pancreatic Cancer


3. TAS-118 (S-1 plus leucovorin) versus S-1 in gemcitabine-refractory advanced pancreatic cancer: A randomized, open-label, phase III trial (GRAPE trial).

Meeting: 2017 ASCO Annual Meeting Abstract No: 4099 First Author: Makoto Ueno
Category: Gastrointestinal (Noncolorectal) Cancer - Pancreatic Cancer