Ariad Pharmaceuticals Inc fka ARIA

[grandma_of_jbraika]

Despite the small size and the relative heterogeneity of this Ponatinib cohort, the obvious caveats and bias of such a study, despite high efficacy rates, Ponatinib induces significant high CV events in CP CML pts, after a relatively short period of exposure to this compound as compared to a historical cohort of Nilotinib-treated pts. The role of prior Nilotinib exposure remains to be determined. These results should promote an extreme vigilance especially in older pts with known CV risk factors that will need to be strictly controlled and monitored. A preventive anti-thrombotic prophylaxis might be useful since Ponatinib initiation.
https://ash.confex.com/ash/2013/webprogram/Paper59574.html

The above is the conclusion of the French investigators (Nicolini et al., 2013 ASH meeting abstract #4020).

In principle of statistics, a small data sample is not sufficient to make a factual conclusion. If the cohort size were 1, the SAE rate could be 100%.

Despite the small size and the relative heterogeneity of this Ponatinib cohort (only 19 patients), despite the obvious caveats and bias of such a study as stated by the French investigators themselves, despite the French study is obviously biased and therefore the justification of its conclusion is questionable, the paid pumper/basher at Oppenheimer biasedly uses the questionable conclusion in support of the FDA's intentionally exaggerated SAE rates.

The FDA found increased SAE rates (48% and 24% in PACE Phase I and II).
Elevated SAEs also found by other investigators: A study from French investigators (Nicolini et al., 2013 ASH meeting abstract #4020) found that in a cohort of 19 CML patients on Iclusig, 42% experienced CV events after a median of 8.5 months on drug, strikingly worse than a historical cohort of nilotinib-treated patients.
Source: Oppenheimer/Ferreiro, December 6, 2013