Oncolytics Collaborators Present Positive Updated U.K. Phase I/II Trial Results in Advanced Solid Cancers
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Oncolytics Biotech Inc. has announced that a poster presentation covering updated results of its Phase I/II U.K. trial (REO 011) of REOLYSIN® combined with paclitaxel/carboplatin for patients with advanced cancers was presented at the ASCO 2010 Annual Meeting in Chicago, IL.
The poster entitled "Phase I/II Study of Oncolytic Reovirus Plus Carboplatin/Paclitaxel in Patients with Advanced Solid Cancers with Emphasis on Squamous Cell Carcinoma of the Head and Neck," (SCCHN) covers previously disclosed response data but includes new overall survival data.
"Although this data has been derived from a single arm study, we feel it is both compelling and supportive of our decision to advance into a pivotal trial in this indication. It also supports our approach to the design of that study and the related statistical analysis," said Dr. Brad Thompson, President and CEO of Oncolytics. "We are eager to see if we can duplicate these results in a larger group of patients in our Phase III study which is now open to enrolment."
The researchers reported that 31 patients were enrolled (24 males; median age 59 years) with head and neck cancer (n=24), melanoma (n=4), peritoneal/endometrial cancer (n=2), or sarcoma (n=1).
In the dose-escalation phase of the study, there were no dose-limiting toxicities. Grade 3/4 toxicities included anaemia, leucopenia, neutropenia, lymphopenia, thrombocytopenia, infection and hypotension. In the Phase 1 study, partial responses (PR) were noted in two of five patients with head and neck cancer.
The Phase 2 study treated head and neck cancer patients at the maximum dose level (3 x 10(10) TCID(50)) in order to further assess tumor response. In total, 19 patients with head and neck cancer received at least two cycles and were evaluable for response.
Most were SCCHN patients refractory to previous platinum-based chemotherapy for recurrent/metastatic disease. Partial responses were seen in eight patients (42%) and stable disease (SD) in six (32%). One additional PR and one SD were observed among four patients with malignant melanoma.
The mean overall survival (OS) in 24 treated head and neck cancer patients is more than eight months, with four patients currently still alive. The mean OS of the patients experiencing PR and PR plus SD is statistically significantly greater than the mean survival of those patients experiencing progressive disease (PD) (hazard ratio 0.2, p=0.0249 and hazard ratio 0.27, p=0.04, respectively, with a 95% confidence interval).
The researchers concluded that intravenous administration of reovirus in combination with carboplatin/paclitaxel is a safe and well-tolerated combination with promising anticancer activity in SCCHN. Further evaluation of this combination in a randomized Phase III trial in SCCHN is underway.
The poster entitled "Phase I/II Study of Oncolytic Reovirus Plus Carboplatin/Paclitaxel in Patients with Advanced Solid Cancers with Emphasis on Squamous Cell Carcinoma of the Head and Neck," (SCCHN) covers previously disclosed response data but includes new overall survival data.
"Although this data has been derived from a single arm study, we feel it is both compelling and supportive of our decision to advance into a pivotal trial in this indication. It also supports our approach to the design of that study and the related statistical analysis," said Dr. Brad Thompson, President and CEO of Oncolytics. "We are eager to see if we can duplicate these results in a larger group of patients in our Phase III study which is now open to enrolment."
The researchers reported that 31 patients were enrolled (24 males; median age 59 years) with head and neck cancer (n=24), melanoma (n=4), peritoneal/endometrial cancer (n=2), or sarcoma (n=1).
In the dose-escalation phase of the study, there were no dose-limiting toxicities. Grade 3/4 toxicities included anaemia, leucopenia, neutropenia, lymphopenia, thrombocytopenia, infection and hypotension. In the Phase 1 study, partial responses (PR) were noted in two of five patients with head and neck cancer.
The Phase 2 study treated head and neck cancer patients at the maximum dose level (3 x 10(10) TCID(50)) in order to further assess tumor response. In total, 19 patients with head and neck cancer received at least two cycles and were evaluable for response.
Most were SCCHN patients refractory to previous platinum-based chemotherapy for recurrent/metastatic disease. Partial responses were seen in eight patients (42%) and stable disease (SD) in six (32%). One additional PR and one SD were observed among four patients with malignant melanoma.
The mean overall survival (OS) in 24 treated head and neck cancer patients is more than eight months, with four patients currently still alive. The mean OS of the patients experiencing PR and PR plus SD is statistically significantly greater than the mean survival of those patients experiencing progressive disease (PD) (hazard ratio 0.2, p=0.0249 and hazard ratio 0.27, p=0.04, respectively, with a 95% confidence interval).
The researchers concluded that intravenous administration of reovirus in combination with carboplatin/paclitaxel is a safe and well-tolerated combination with promising anticancer activity in SCCHN. Further evaluation of this combination in a randomized Phase III trial in SCCHN is underway.
