Biotech Values

[DewDiligence]

Tofacitinib Scorecard

Yesterday, PFE reported positive Tofacitinib-vs-Methotraxate data in the first-line setting in a study called ‘ORAL Start’; this is the sixth (!) positive phase-3 study involving Tofacitinib:

http://finance.yahoo.com/news/pfizer-announces-positive-top-line-141200791.html

ORAL Start, an ongoing two-year study in methotrexate (MTX)-naïve patients with moderate-to-severe active RA, randomized to receive tofacitinib 5 or 10 mg twice-daily (BID) as monotherapy or MTX, met its primary endpoints at both the 5 and 10 mg BID doses. Tofacitinib was found to be superior to MTX with statistically significant changes shown in inhibiting structural damage, as measured by change from baseline in modified Total Sharp Score (mTSS), and in reducing signs and symptoms of RA, as measured by ACR70 response rates. Both primary endpoints assessed tofacitinib versus MTX at six months. The data reported are from a planned analysis at one year.

No new safety signals emerged in the ORAL Start study, and the safety profile of tofacitinib remained consistent with that seen previously in the clinical development program.

Although ‘ORAL Start’ is a phase-3 study, it is not part of the NDA/MAA package currently under review by the FDA and EMA. That package consists of five other positive phase-3 studies as follows:

• ‘ORAL Solo’ – Tofacitinib vs placebo in the second line (#msg-56398000)

• ‘ORAL Scan’ – MTX ± Tofacitinib in the second line (#msg-62106415).

• ‘ORAL Sync’ – DMARD (investigator’s choice) ± Tofacitinib in the second line (#msg-60574470);

• ‘ORAL Step’ – MTX ± Tofacitinib in the third line for patients who failed a TNF-a drug in the second line (#msg-62546621); and

• ‘ORAL Standard’ – Tofacitinib vs Humira in the second line as an addend to MTX for patients who failed MTX in the first line (#msg-62546621).

If there’s a reason to not approve this drug, it hasn’t surfaced yet!