Mer­ck­'s Keytru­da nets an­oth­er ap­proval, this time in triple neg­a­tive breast can­cer. Can it catch up to Tecen­triq?

An­oth­er day, an­oth­er win for Mer­ck’s block­buster Keytru­da.

The FDA has grant­ed ac­cel­er­at­ed ap­proval for the cash cow com­bined with chemother­a­py in triple neg­a­tive breast can­cer, giv­ing the drug the green light in its 18th dif­fer­ent can­cer. Mon­day’s new in­di­ca­tion comes for pa­tients with PD-L1-ex­press­ing tu­mors with a Com­bined Pos­i­tive Score of at least 10.

Mer­ck not­ed that due to the na­ture of the ac­cel­er­at­ed ap­proval, the thumbs up is con­tin­gent up­on con­fir­ma­to­ry tri­als.

Da­ta for the ap­proval first came back in Feb­ru­ary, when the Keynote-355 tri­al demon­strat­ed Keytru­da plus chemo sig­nif­i­cant­ly im­proved pro­gres­sion-free sur­vival com­pared to chemo by it­self. The study showed that, in the tar­get pop­u­la­tion with a CPS of at least 10, the com­bi­na­tion re­duced the risk of dis­ease pro­gres­sion or death by 35% with a me­di­an PFS of 9.7 months, against 5.6 months in the place­bo arm.

On safe­ty, the Feb­ru­ary da­ta showed 2.5% of all pa­tients in the drug arm saw fa­tal ad­verse events, in­clud­ing car­diac ar­rest and sep­tic shock, with se­ri­ous side ef­fects ap­pear­ing in 30% of pa­tients. Keytru­da was dis­con­tin­ued due to ad­verse events in 11% of pa­tients.

Front­line triple neg­a­tive breast can­cer is a par­tic­u­lar­ly dif­fi­cult in­di­ca­tion to treat, as the growth of the can­cer is not fu­eled by the hor­mones es­tro­gen and prog­es­terone, or by the HER2 pro­tein. It’s one of the rare fields in which Roche’s PD-L1 Tecen­triq has en­joyed a head start over Keytru­da and Op­di­vo, the lead­ers in the check­point race, as Tecen­triq is ap­proved in com­bi­na­tion with Abrax­ane for this in­di­ca­tion.

Back in May 2019, Mer­ck con­ced­ed a fail­ure in the are­na af­ter a Phase III study flopped on over­all sur­vival. But a few months lat­er, the phar­ma turned things around af­ter dis­cov­er­ing a neoad­ju­vant reg­i­men of Keytru­da and chemo — fol­lowed by Keytru­da monother­a­py af­ter surgery — in­duced a high­er patho­log­i­cal com­plete re­sponse rate.

Though ex­ecs pre­sent­ed that as a pos­i­tive, some an­a­lysts didn’t paint as sun­ny a pic­ture. This past Feb­ru­ary, when the Keynote-355 topline da­ta was first pub­lished, SVB Leerink’s Daina Gray­bosch point­ed out that be­cause on­ly pa­tients with a CPS of at least 10 ap­peared to ben­e­fit, in­stead of a score of at least 1, it won’t be able to treat as broad a pop­u­la­tion as Tecen­triq. Roche, she not­ed, al­so has about a two-year head start.

A Mer­ck spokesper­son al­so had this to say about the CPS and IC per­cent­ages:

In TNBC, we mea­sure PD-L1 with a com­bined pos­i­tive score (CPS). The CPS in­cludes stain­ing for tu­mor cells, as well as tu­mor-in­fil­trat­ing im­mune cells and it is not a per­cent­age. We be­lieve CPS ≥10 is rough­ly equiv­a­lent to how Roche scores PD-L1+ pa­tients (IC>=1% based on the SP142 as­say) on tu­mor-in­fil­trat­ing im­mune cells (IC). The preva­lence of the PD-L1 pos­i­tive pop­u­la­tion in TNBC whether by CPS of greater than or equal to 10 or IC of 1% is both about 40%.

Keytru­da is al­ready one of the best-sell­ing drugs in the world, hav­ing notched rough­ly $3.9 bil­lion in the first half of 2020 alone. Some have pre­dict­ed the drug may over­take Ab­b­Vie’s Hu­mi­ra as the top sell­er with­in the next few years, with the most op­ti­mistic es­ti­mate pegged for $22.2 bil­lion in sales by 2025.

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