Roche silent­ly whisks away its lead $1.7B Ser­agon drug in a Q1 foot­note

Rich Hey­man

Close to three years ago Roche’s Genen­tech team came in and bought out Ser­agon from Rich Hey­man for $725 mil­lion in cash and an­oth­er bil­lion dol­lars in mile­stones, herald­ing the po­ten­tial for se­lec­tive es­tro­gen re­cep­tor de­graders to “one day re­de­fine the stan­dard of care for hor­mone re­cep­tor-pos­i­tive breast can­cer.”

To­day, the phar­ma gi­ant qui­et­ly car­ried the lead drug from that deal out to the curb, not­ing in a foot­note on pro­gram ter­mi­na­tions that it was re­mov­ing the drug GDC-0810 (ARN-810, RG6046) from Phase II.

In re­sponse to a query, Roche says that 0810 is be­ing shelved now so the com­pa­ny can move for­ward with an­oth­er one of Ser­agon’s drugs in the same field that has bet­ter po­ten­tial — and they’re just as in­ter­est­ed in SERDs as ever. Their state­ment:

Genen­tech has de­cid­ed to halt fur­ther clin­i­cal de­vel­op­ment and on­go­ing stud­ies eval­u­at­ing GDC-0810 while we eval­u­ate our strate­gic op­tions for our Se­lec­tive Es­tro­gen Re­cep­tor De­graders (SERDs) pro­gram.
We have learned much about the SERD bi­ol­o­gy with tar­get­ing the es­tro­gen re­cep­tor. Based on cur­rent da­ta, GDC-0927, an­oth­er next-gen­er­a­tion oral SERD, ap­pears to have greater po­ten­tial than GDC-0810 to be a best-in-class SERD mol­e­cule. We have de­cid­ed to move for­ward with GDC-0927 in pa­tients with metasta­t­ic hor­mone re­cep­tor-pos­i­tive/HER2-neg­a­tive breast can­cer build­ing up­on what we have learned in the clin­ic with GDC-0810. In Q1 2015, we ini­ti­at­ed a Phase I dose-es­ca­la­tion tri­al to as­sess the safe­ty, tol­er­a­bil­i­ty, and phar­ma­co­ki­net­ics of GDC-0927 in pa­tients with metasta­t­ic hor­mone re­cep­tor-pos­i­tive/HER-neg­a­tive breast can­cer who have pro­gressed af­ter re­ceiv­ing cur­rent an­ti-hor­mon­al med­i­cines.
Genen­tech re­mains com­mit­ted to con­tin­u­ing to in­vest in SERD bi­ol­o­gy and nov­el SERD ther­a­pies. We be­lieve in­ves­ti­ga­tion­al next-gen­er­a­tion oral SERDs could one day re­de­fine the stan­dard of care for hor­mone re­cep­tor-pos­i­tive breast can­cer.

The re­ver­sal marks an un­usu­al set­back for Genen­tech and Roche, which rarely spend that kind of mon­ey on an ex­per­i­men­tal as­set. He­len Thomas, who was then writ­ing Heard on the Street for the Wall Street Jour­nal, found it “dis­con­cert­ing” at the time.

“Rarely in oth­er sec­tors,” she not­ed, “do com­pa­nies shell out vast sums for as­sets that could quite pos­si­bly amount to noth­ing.”

Ser­agon was what was left af­ter J&J came in and bought Aragon — Hey­man’s San Diego biotech cre­at­ed to pur­sue the in­sights of not­ed in­ves­ti­ga­tor Charles Sawyers — in one of its bil­lion-dol­lar buy­outs ($650 mil­lion in cash). Stan­dard ther­a­pies for breast and prostate can­cer are de­signed to block the ef­fect of the hor­mones, act­ing like “glue in the lock” of hor­mone re­cep­tors, then-Aragon CEO Hey­man told me back in 2010. But over time, pa­tients be­come treat­ment re­sis­tant and the ther­a­py can wind up fu­el­ing the can­cer. Hey­man called his lead ther­a­py for prostate can­cer “su­per glue. It tru­ly blocks the re­cep­tor in this re­sis­tant state.”

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BeiGene CEO John Oyler at an Endpoints event in Shanghai, October 2018 (Credit: Endpoints News/PharmCube)

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