On May 27, 2022 Targovax ASA (OSE: TRVX), reported that publication of the two ONCOS-102 abstracts accepted for presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 3-7 June 2022 (Press release, Targovax, MAY 27, 2022, View Source [SID1234615167]). The posters will present clinical results from the completed phase 1/2 trials in malignant pleural mesothelioma and in heavily pre-treated, MS-stable colorectal or ovarian cancer with peritoneal metastasis.
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First poster title: Final survival outcomes and immune biomarker analysis of a randomized, open-label, phase I/II study combining oncolytic adenovirus ONCOS-102 with pemetrexed/cisplatin (P/C) in patients with unresectable malignant pleural mesothelioma (MPM)
Session Title: Lung Cancer – Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
Time: Monday 6 June 2022, 8:00-11:00 AM CDT, Abstract 8561
Presenter: Dr Santiago Ponce, Medical Oncology, Hospital 12 Octubre, Madrid, Spain
The poster summarizes the overall findings from the completed, randomized phase 1/2 trial in 31 patients with MPM; 20 patients received intra-tumoral (IT) ONCOS-102 in combination with standard of care (SoC) chemotherapy and 11 patients in a control group received SoC chemotherapy only.
In the randomized part of the trial, the 30-month overall survival (OS) rate was 34.3% in the ONCOS-102 treated group (n=14) vs. 18.2% in the SoC-only control group (n=11). In first-line patients, the ONCOS-102 group achieved a median overall survival (mOS) of 25.0 months (n=8) vs. 13.5 months mOS in the SoC-only control group (n=6). The ONCOS-102 first-line mOS compares favorably to SoC historical control studies reporting mOS of 12-16 months1, as well as the combination of nivolumab and ipilimumab which demonstrated mOS of 18.1 months in a phase 3 trial that led to FDA approval2. Tumor biopsy immune cell analyses revealed strong T-cell infiltration induced by ONCOS-102 in patients with partial response (PR) or stable disease (SD), but not in progressors. These observations were confirmed by RNAseq gene expression analysis. The breadth and strength of immune response induced by ONCOS-102 correlated with both tumor response and survival. Further clinical trials in MPM are clearly warranted to validate these positive findings in a larger patient cohort.
Second poster title: Study to evaluate intraperitoneal (IP) ONCOS-102 with systemic durvalumab in patients with peritoneal disease who have epithelial ovarian (OC) or metastatic colorectal cancer (CRC): Phase 2 results
Session Title: Development Therapeutics, Immunotherapy
Time: Sunday 5 June 2022, 8:00-11:00 AM CDT, Abstract 2600
Presenter: Dr Dmitriy Zamarin, Memorial Sloan Kettering Cancer Center, New York, USA
The poster reports clinical data from the ONCOS-102 phase 1/2 combination trial with anti-PD-L1 checkpoint inhibitor durvalumab in heavily pre-treated, MS-stable CRC (n=36) or OC (n=19) with peritoneal metastases. This is a patient population with few treatment alternatives that only offer marginal efficacy and where checkpoint inhibitor monotherapy does not have any meaningful activity. The trial was managed by an external consortium with Ludwig Cancer Research as sponsor, where Targovax was a collaboration partner.
This is the first time ONCOS-102 has been administered IP and in combination with an anti-PD-L1 checkpoint inhibitor. IP delivery of ONCOS-102 was demonstrated to be feasible and well-tolerated, both as monotherapy and in combination with systemic durvalumab. Whereas the initial OC cohort did not meet the efficacy criteria and was closed, the initial CRC cohort met the efficacy criteria and was expanded. In the full CRC cohort (n=36) two patients remained progression free at the end of the study (week 24), but the primary efficacy endpoint of 4 patients remaining progression free at week 24 was not met.
Tumor biopsy immune cell analysis showed increased T-cell infiltration in several patients, confirming that IP administered ONCOS-102 can induce immune activation in heavily pre-treated, immunologically silent solid tumors. Of note, the selected IP dose was the same as used for IT delivery of ONCOS-102 (3×1011 V.P.), although IP delivery is expected to result in lower tumor exposure to the virus relative to IT. Hence, higher doses of IP delivered ONCOS-102 could potentially enhance both the immunological response and clinical activity.
Dr. Lone Ottesen, Chief Medical Officer of Targovax, said: "We are very pleased to have two ONCOS-102 studies accepted for presentation at ASCO (Free ASCO Whitepaper) this year, which is a very important forum to showcase and discuss our clinical data with international experts in the field. In our exploratory clinical program we have now demonstrated that ONCOS-102 can be delivered safely intra-tumorally and intra-peritoneally in combination with PD-1 and PD-L1 checkpoint inhibitors, as well as chemotherapy. Importantly, we have also seen robust immunological and clinical activity in solid tumors of different origins. This gives us confidence to bring ONCOS-102 forward into later stage development, with the first step being a multi-cohort phase 2 trial in PD1-refractory melanoma where we will test several I-O combinations, including the second-generation anti-CTLA4 checkpoint inhibitor botensilimab."
About ASCO (Free ASCO Whitepaper)
American Society of Clinical Oncology Annual Meeting, ASCO (Free ASCO Whitepaper) 2022 will be held in McCormick Place, Chicago, Illinois, United States between 3-7 June 2022.
The 2022 ASCO (Free ASCO Whitepaper) Annual Meeting Program will offer presentations on the latest research in cancer care. This year’s program will feature sessions complementing the meeting’s theme: Advancing Equitable Cancer Care Through Innovation.