FDA OKs Mer­ck’s Keytru­da for Hodgkin lym­phoma, a first in blood can­cer


Mer­ck has racked up an­oth­er FDA ap­proval for Keytru­da, this time for clas­si­cal Hodgkin lym­phoma, mark­ing the PD-1 block­er’s first green-light for use in liq­uid tu­mors.

Reg­u­la­tors hand­ed out the OK for pa­tients who had al­ready failed at least three ther­a­pies.

The agency based this ap­proval on the da­ta Mer­ck col­lect­ed in 210 pa­tients from the KEYNOTE-087 tri­al, which demon­strat­ed an over­all re­sponse rate of 69%, with a com­plete re­mis­sion rate — no de­tectable can­cer — of 22% and a par­tial re­mis­sion rate of 47%.

The ap­proval was a first for Mer­ck, but it comes 9 months af­ter Op­di­vo was ap­proved in cHL. Sun­Trust sug­gests that Mer­ck’s la­bel could have im­pli­ca­tions for Seat­tle Ge­net­ics’ Ad­cetris. They wrote:

We be­lieve Keytru­da’s broad la­bel pro­vides a new al­ter­na­tive to clas­si­cal Hodgkin lym­phoma pa­tients who have pri­ma­ry re­frac­to­ry dis­ease, an in­di­ca­tion for which Ad­cetris is not yet ap­proved. For ad­vanced cHL, we be­lieve pri­ma­ry re­frac­to­ry dis­ease oc­curs in up to 20% of pa­tients on stan­dard front-line reg­i­mens (AB­VD, al­ter­na­tive AB­VD/MOPP) and in ~10% of pa­tients on more in­ten­sive reg­i­mens,

Roger M. Perl­mut­ter, Mer­ck

Mer­ck had been rel­e­gat­ed to the num­ber two po­si­tion in the big check­point mar­ket, trail­ing well be­hind adop­tion of Bris­tol-My­ers Squibb’s Op­di­vo. Then Op­di­vo ex­pe­ri­enced a se­ries of set­back late last year that turned the mar­ket up­side down, fa­vor­ing Keytru­da and forc­ing Bris­tol-My­ers to shake up its re­search or­ga­ni­za­tion.

Said Dr. Roger M. Perl­mut­ter, pres­i­dent, Mer­ck Re­search Lab­o­ra­to­ries:

To­day’s ap­proval – the first for Keytru­da in a hema­to­log­ic ma­lig­nan­cy – re­in­forces the hope that im­munother­a­py will prove use­ful in a wide va­ri­ety of can­cers.

“For the pa­tients with clas­si­cal Hodgkin lym­phoma who are not cured with ex­ist­ing treat­ments, there are lim­it­ed op­tions, and treat­ing their dis­ease be­comes more chal­leng­ing,” added Dr. Craig Moskowitz, clin­i­cal di­rec­tor, di­vi­sion of hema­to­log­ic on­col­o­gy, Memo­r­i­al Sloan Ket­ter­ing Can­cer Cen­ter. “This ap­proval is an im­por­tant step for­ward in treat­ing these pa­tients, who are gen­er­al­ly young and have a par­tic­u­lar­ly poor prog­no­sis, and gives us the op­por­tu­ni­ty to help pa­tients in their fight against this dev­as­tat­ing dis­ease.”

5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Hal Barron, GSK via YouTube

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Janet Woodcock (AP Images)

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Charlie Fuchs, Roche and Genentech global head of product development for oncology and hematology (Yale Cancer Center)

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Jonathan Weissman (MIT)

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Michelle McMurry-Heath, BIO CEO (BIO via YouTube)

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Janet Woodcock and Joshua Sharfstein (AP, Images)

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