Except from TC analyst - July 21 below. No mention of disappointment in AIPAC or P3 trial - quite the contrary.
AIPAC P3 trial protocols will be slightly different and Paclitaxel (Taxol - BMS?) will likely be administered for the duration of efti and not only 6 months as it was in P2b....sub-groups we know statistically benefit but FDA/EMA may insist on an 'all comer' trial, which would include all age groups and pre-conditions.....
My primary concerns are $cost - funding and time to interim/final OS data - could be 3 years (longer the better for patients), which is why 2b primary was PFS chosen (which actually backfired).....long time between value adding inflection data, which is why I hope BP take this on...
IMM plans to fund a Phase III trial of efti/paclitaxel combo therapy in hormone receptor positive, HER2 negative mBC.
In our view the (non-significant) 17% improvement in overall survival (OS) reported in the interim AIPAC data at SABC in December provides an unbiased estimate of the effect that might be expected in Phase III (ie a 50% chance that OS benefit would be 17% or better), and warrants investigation in Phase III.
IMM indicated it is planning a 500 patient trial with 90% power to detect a 30% OS benefit (ie HR ≤0.70); we would rather
see a larger trial that is powered to detect the OS benefit that is reported in the final analysis of AIPAC, which is due in the next few months. Paclitaxel is widely used in first line chemotherapy in this patient population in Europe and Australia, so improved survival in this setting would be a significant advance for patients.
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