2019 vs 2021 vs 2023 results in ONCYs Phase 1b/2 pancreatic cancer studies are compared below first evaluating pelareorep in combination with pembrolizumab in advanced pancreatic cancer, and then, in ONCYs GOBLET Phase 1/2 clinical trial evaluating pelareorep in combination with atezolizumab + nab-paclitaxel in advanced/metastatic pancreatic cancer.
https://d1io3yog0oux5.cloudfront.net/_317335d214f0f2271588d77471e4d933/oncolyticsbiotech/db/343/2239/pdf/Mahalingam+et+al%2C+EMSO+July+2015.pdf
The initial 2019 survival analysis for 33 patients in difficult-to-treat second line pancreatic cancer patients who were treated with pelareorep + pembrolizumab without chemotherapy resulted in one PR, 23 SD and five PD as best response, a median PFS of 4 months and a median OS of 10.2 months, with 1- and 2-year survival of 45% and 24%, respectively.
https://oncolyticsbiotech.com/press_releases/oncolytics-biotechr-announces-publication-of-positive-reo-024-study-results-for-pelareorep-in-combination-with-keytrudar-in-patients-with-advanced-pancreatic-adenocarcinoma/
The 2021 analysis of the 2019 Phase 1b/2 patients who were treated with pelareorep in combination with pembrolizumab demonstrated that 42% disease control was achieved in difficult-to-treat second line pancreatic cancer patients despite the absence of chemotherapy in the treatment regimen, with one patient achieviing a partial response and four patients achieviing stable disease.
https://oncolyticsbiotech.com/press_releases/oncolytics-biotech-announces-clinical-and-biomarker-data-demonstrating-clinical-proof-of-concept-for-pelareorep-checkpoint-inhibitor-combination-in-pancreatic-cancer/
On October 16, 2023 the GOBLET Phase 1/2 metastatic pancreatic cancer abstract was released at ESMO and reported on results in patients who were treated with pelareorep + pembrolizumab + chemotherapy (nab-paclitaxel). Preliminary results were updated PDAC data showing a median PFS of 7.2 months, interim median overall survival of 10.6 months, expansion of both pre-existing and new T-cell clones and a 6-month survival rate of 82% in a patient population comprised of patients where 92% presented with metastatic disease, 69% in the liver - the worst of the worst - which historically only 10% survive longer than one (1) year.
The results showed that 8 of 13 evaluable patients had a partial response (PR) in a patient population which historically have not responded to in the past. A partial response (PR) is defined as at least a 30% decrease in the sum of the target lesions.
This is the first time that any study demonstrated that a checkpoint inhibitor in any I/O combination showed effectiveness in the treatment of advanced/metastatic pancreatic cancer (PDAC) .
By comparision , a recently published phase I study of nivolumab and the anti-CC chemokine receptor 4 antibody mogamulizumab in patients with advanced solid tumors included 15 patients with PDAC. The authors reported 1 confirmed partial response and 2 unconfirmed partial responses in patients with PDAC.
In another study the observed efficacy of durvalumab plus tremelimumab therapy and durvalumab monotherapy in a 65 patient Phase 2 study reflective of a population of patients with mPDAC who had poor prognoses and rapidly progressing disease, the objective response rate was only 3.1%, and no patients (0.0%) responded to durvalumab monotherapy.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6647002/