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2019 ASCO Annual Meeting!

Session: Gastrointestinal (Noncolorectal) Cancer

Type: Poster Session

Time: Monday June 3, 8:00 AM to 11:00 AM

Location: Hall A

A phase I study of oncolytic immunotherapy of metastatic neuroendocrine tumors using intralesional rose bengal disodium: Cohort 1 results.


Gastrointestinal (Noncolorectal) Cancer

2019 ASCO Annual Meeting

Abstract No:

Poster Board Number:
Poster Session (Board #207)

J Clin Oncol 37, 2019 (suppl; abstr 4102)

Author(s): Timothy Jay Price, Gabby Cehic, Eric Andrew Wachter, Ian Kirkwood, Rubin Sebbon, Lisa Leopardi, Jessic Reid, Anas Alawawdeh, Susan J Neuhaus, Guy Maddern; Queen Elizabeth Hospital, University of Adelaide, Adelaide, Australia; The Queen Elizabeth Hospital, Adelaide, Australia; Provectus Biopharmaceuticals, Inc, Knoxville, TN; Department of Nuclear Medicine, Royal Adelaide Hospital, and The University of Adelaide, Adelaide, Australia; The Queen Elizabeth Hospital, Woodville, Australia; University of Adelaide and Royal Adelaide Hospital, Adelaide, Australia

Abstract Disclosures


Background: Metastatic neuroendocrine neoplasms (mNEN’s) originating in the gastrointestinal tract are frequently slow growing yet both symptom and disease control remain important. Treatment options include resection, chemoablation, systemic somatostatin analogues (SSA) or peptide receptor radionuclide therapy (PRRT), but additional options are needed and one such option is hepatic intralesional (IL) rose bengal disodium (PV-10), an oncolytic immunotherapy under development for solid tumours. Methods: This phase 1 study is evaluating the safety, tolerability and reduction of biochemical markers and symptoms resulting from percutaneous administration of PV-10 in 12 subjects with progressive mNEN with hepatic lesions not amenable to resection or other potentially curative therapy. Target lesion(s) must be 1.0 - 3.9 cm in longest diameter. In Cohort 1 (n = 6) subjects receive PV-10 to a single hepatic lesion per treatment cycle, and can receive PV-10 to additional uninjected hepatic lesions ≥6 weeks after prior injection. Cohort 2 (n = 6) subjects may receive injection of multiple lesions per treatment cycle. The primary endpoint is safety. Secondary endpoints include objective response rate (ORR) assessed by contrast enhanced CT and 68Ga-DOTATATE PET, biochemical response (CgA) and patient-reported outcome (EORTC QLQ-C30 and GI.NET21). Results: Cohort 1 has fully enrolled, with 4 of 6 subjects male, median age 65yrs, range 47-72. Primary sites were: small bowel 3, pancreas 2, caecal 1; grade: Gd1 = 5, Gd2 = 1. All patients received prior SSA and PRRT. Median CgA was 645 (range 30-2819). To date 1 subject has received 4 PV-10 treatment cycles, 1 has received 2 cycles, and 4 have received a single cycle. Toxicity has been acceptable, including pain post procedure, carcinoid flare and nausea. LFT’s have remained stable. Overall QOL score was stable for 5 of 6 subjects. ORR in injected lesions is 50% (progression in 1 subject), with overall disease control of 84%. CgA response: 5 stable, 1 progression. One subject with “carcinoid pellagra” had rash resolution. Response follow-up is ongoing and additional efficacy and functional data will be presented. Conclusions: Hepatic IL PV-10 elicited no safety concerns with encouraging evidence of both local and systemic disease control. Enrolment to Cohort 2 is underway. Clinical trial information: NCT02693067

Other Abstracts in this Sub-Category:


1. Prospective randomized phase II trial of pazopanib versus placebo in patients with progressive carcinoid tumors (CARC) (Alliance A021202).

Meeting: 2019 ASCO Annual Meeting Abstract No: 4005 First Author: Emily K. Bergsland
Category: Gastrointestinal (Noncolorectal) Cancer - Neuroendocrine/Carcinoid


2. An open label, single-arm, two-stage, multicenter, phase II study to evaluate the efficacy and safety of TLC388 as second-line treatment in subjects with poorly differentiated neuroendocrine carcinomas (TCOGT1Z14).

Meeting: 2019 ASCO Annual Meeting Abstract No: 4101 First Author: Ming-Huang Chen
Category: Gastrointestinal (Noncolorectal) Cancer - Neuroendocrine/Carcinoid


3. A phase II, open label, multicenter trial of avelumab in patients with advanced, metastatic high-grade neuroendocrine carcinomas NEC G3 (WHO 2010) progressive after first-line chemotherapy (AVENEC).

Meeting: 2019 ASCO Annual Meeting Abstract No: 4103 First Author: Christian Fottner
Category: Gastrointestinal (Noncolorectal) Cancer - Neuroendocrine/Carcinoid