In OSL's Quarterly Report:
PositiveOverall Survival data from PanCo Study
Duringthe quarter, the Company shared positive Overall Survival data for its PanCostudy at the American Society of Clinical Oncology (ASCO) Annual Meeting 2019in Chicago.
ThePanCo study is an international multi-institutional, single arm study conductedacross 12 sites in Australia, UK and Belgium. The aim of the study is tofurther investigate the safety, efficacy, feasibility and performance of theOncoSil device when implanted intra-tumorally in patients with unresectablelocally advanced pancreatic cancer (LAPC).
The study shows promising survivalestimates with mean overall survival of 16 months. The accepted populationmedian overall survival estimates of patients with LAPC is only 9-11 months.
Theresults are comparable to, and in many cases surpasses, that of the bestavailable published literature in the patient population.
The study data demonstrates an unequivocal and direct clinicalbenefit for patients andthis, alongside other relevant outcome measures, have been included in thepackage submission and will be discussed with the BSI and COC.
Based on the 16 mths vs 11 mth survival rate improvement, it is 45% better than any other existing treatment! But that is based on the un-resectable LAPC population. There are 4 stages of cancer, un-resectable LAPC might well be half of those in Stage 2. If COC is using the TOTAL pancreatic cancer patient population as a base (which could be 8 times larger, say). Then 45% div by 8 = 6% improvement. No wonder it has been deemed "insufficient clinical benefit" by the COC.
The patient population base could well be the contentious issue IMHO.
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