Gender matters in pair of Oncolytics clinical trials

Company’s oncolytic virus Reolysin shows much better success with women in colorectal cancer and NSCLC

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CALGARY, Alberta—They are still early-stage results, but Oncolytics Biotech reported data May 19 from two studies with their oncolytic virus, Reolysin, which showed—to the company’s surprise—that women had much better success in two indications: colorectal cancer and non-small cell lung cancer (NSCLC).
This is encouraging, according to the company, because the data suggest that the inclusion of Reolysin in the treatment combination (particularly with immunotherapies) may have a profound impact on women, potentially leading to personalized, gender-specific treatments.
The preliminary data came from a Phase 2 clinical study of Reolysin in NSCLC (in which patients with non-squamous cell histology were treated with Reolysin given in combination with pemetrexed vs. pemetrexed alone and patients with squamous cell histology were treated with Reolysin given in combination with docetaxel vs. docetaxel alone) and a Phase 2 clinical trial of Reolysin in combination with FOLFOX-6 and bevacizumab (Avastin) in patients with advanced or metastatic colorectal cancer.
“We are encouraged by [the colorectal cancer study data] suggesting that the inclusion of Reolysin in the treatment combination may have a profound impact on response rates for women with colorectal cancer,” said Dr. Brad Thompson, president and CEO of Oncolytics. “Various immune-based therapies have demonstrated a profile where patients derive tumor response and overall survival benefit with limited or no impact on progression-free survival. Reolysin, as an oncolytic virotherapy, appears to be demonstrating a similar profile in female patients with advanced or metatstatic colorectal cancer. This is a further example of our sponsored randomized Phase 2 program identifying specific indications, patient populations and endpoints for examination in future trials to be conducted by Oncolytics. Building on these findings, we intend to conduct a study in female metastatic colorectal cancer patients using this treatment regimen combined with a checkpoint inhibitor.”
And, of the NSCLC study, he said: “It’s very encouraging to see both a genetic and gender linkage to progression-free survival and overall survival in these difficult-to-treat patient populations. This is the first randomized data we have generated in lung cancers that correlates genetic status to patient outcomes.”
Getting back to the colorectal cancer trial, Oncolytics conducted an additional analysis of all patients (both male and female) with liver metastases, with or without metastases to other sites. For patients who had metastases to the liver, those treated with Reolysin had objective tumor response rates of 55 percent, compared to 28.6 percent for those who did not receive Reolysin. For the patients who did not have liver metastases, there was no statistically significant difference in response rate.
“When cancer spreads to the liver, treatment becomes more difficult, leading to a drop in response and survival rates,” said Thompson. “Based on these randomized data, we believe that Reolysin may have particular utility in those patients who have late-stage colorectal cancer with liver metastases.”
The take at was not as upbeat as Oncolytics’ assessment, with a headline of “Oncolytics Bio’s Reolysin falls flat in mid-stage study in colorectal cancer.” In that article, Seeking Alpha noted that Reolysin in combination with FOLFOX-6 and Avastin failed to beat FOLFOX-6 and Avastin alone, adding that “In an apparent attempt to salvage something, the company conducted an additional analysis in patients with liver metastases” and noting that “Female patients offered the only ray of hope,” with overall response of  63.2 percent for the Reolysin group vs. 23.8 percent for the control group.

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