Although a next-gen, pan-EGFR inhibitor could address the EGFR TKI frontline market at-large, approx. 36,000 patients per annum (adv. stage/dev. country), with several good TKIs approved for front line (erlotinib/gefitinib, or 2nd-gen afatinib) its unlikely '788 would get much traction, unless a squeaky clean safety profile makes it well-suited for combinations with others. For the resistant population, approx. 55% have the T790M+ mutation which rociletinib and osimertinib will soon have approval for, leaving T790M- as an unmet of approx. 16,000 patients. Her2+ mutations could add another unmet need of ~7,000 pts.
Additionally a true pan-EGFR inhibitor could find use in all forms of EGFR TKI resistance.
So assuming '788 is indeed a pan-EGFR inhibitor with "unique features" the TAM could be anywhere from 50,000-75,000 pts, but assuming competition above, and pending, I would estimate population of ~16,000-24,000. |
