Mer­ck touts new da­ta for Keytru­da com­bos in NSCLC at North Amer­i­can con­fer­ence

Mer­ck marched out new da­ta from two stud­ies on Fri­day to back king Keytru­da — the drug that made the Big Phar­ma $11.1 bil­lion last year — in ad­vanced non-small cell lung can­cer (NSCLC).

At the IASLC 2020 North Amer­i­ca Con­fer­ence on Lung Can­cer, Mer­ck read out long-term da­ta from Co­hort G of its Keynote-021 study, which as­sessed Keytru­da in com­bi­na­tion with chemother­a­py. It al­so tout­ed re­sults from a Phase I/II study test­ing Keytru­da and qua­von­limab, its an­ti-CT­LA-4 ther­a­py, as a first-line ther­a­py.

The com­pa­ny plans on div­ing right in­to a Phase III study with the Keytru­da and qua­von­limab com­bo, it an­nounced.

In the Keynote-021 study, pa­tients were giv­en ei­ther Keytru­da with Eli Lil­ly’s chemother­a­py peme­trexed and plat­inum chemother­a­py, or chemother­a­py alone. This par­tic­u­lar Keytru­da com­bi­na­tion was ap­proved by the FDA in 2018 as a first-line treat­ment in non-squa­mous NSCLC pa­tients with no EGFR or ALK ge­nom­ic tu­mor aber­ra­tions.

At a three-year fol­low-up mark, about half of pa­tients in the Keynote-021 treat­ment arm were still alive, as op­posed to 37% of pa­tients on just chemo, ac­cord­ing to Mer­ck. Com­pared to chemo, the Keytru­da cock­tail re­duced risk of death by 29%, with a mean over­all sur­vival of 34.5 months ver­sus 21.1 months, Mer­ck said.

Mer­ck re­port­ed a 58% ob­jec­tive re­sponse rate for the Keytru­da arm, and a 33% rate for the chemo arm. Me­di­an pro­gres­sion-free sur­vival was 24.5 months for those on Keytru­da ver­sus 9.9 months for those on chemother­a­py alone. The Keytru­da arm’s me­di­an du­ra­tion of re­sponse was more than a year longer than the chemother­a­py arm. And 11 of 12 pa­tients —92% — who com­plet­ed two years of treat­ment with Keytru­da were still alive at year three.

No new safe­ty sig­nals were not­ed in the fol­low-up, ac­cord­ing to Mer­ck.

As for the Phase I/II study with qua­von­limab, Mer­ck re­port­ed that re­sults showed an “ac­cept­able safe­ty pro­file with no un­ex­pect­ed tox­i­c­i­ties.” The tri­al test­ed var­i­ous dos­es of the com­bi­na­tion as a first-line ther­a­py, with safe­ty and tol­er­a­bil­i­ty as the pri­ma­ry end­points. Sec­ondary end­points in­clud­ed ob­jec­tive re­sponse rate, pro­gres­sion-free sur­vival, over­all sur­vival and du­ra­tion of re­sponse.

Qua­von­limab was ad­min­is­tered in 25 mg or 75 mg dos­es every three or six weeks along with Keytru­da. About 98% of pa­tients ex­pe­ri­enced any-grade ad­verse events, ac­cord­ing to Mer­ck. Treat­ment-re­lat­ed ad­verse events (TRAEs) oc­curred in 85% of pa­tients, 36% of which were Grade 3 or high­er. The most com­mon TRAEs were in­creased ala­nine amino­trans­ferase, pneu­moni­tis, and in­creased as­par­tate amino­trans­ferase, Mer­ck said.

Par­tic­i­pants who re­ceived 25 mg of qua­von­limab every six weeks had a me­di­an pro­gres­sion-free sur­vival of 7.8 months and a me­di­an over­all sur­vival of 18.1 months, ac­cord­ing to the da­ta. Up­on re­view­ing the da­ta, Mer­ck rec­om­mends this dos­ing for a Phase II study.

Keytru­da is ap­proved to treat a va­ri­ety of can­cers aside from NSCLC, in­clud­ing small cell lung can­cer, melanoma, head and neck squa­mous cell can­cer, and Hodgkin lym­phoma, to name a few. At this year’s ES­MO, Mer­ck an­nounced pos­i­tive Phase III re­sults for Keytru­da as a first-line esophageal can­cer treat­ment in com­bi­na­tion with chemother­a­py.

“Over the last five years, Keytru­da has be­come foun­da­tion­al in the treat­ment of metasta­t­ic lung can­cer. The long-term da­ta from Keynote-021 (Co­hort G) re­in­force the use of Keytru­da in com­bi­na­tion with chemother­a­py in cer­tain ad­vanced lung can­cer pa­tients, while da­ta from our on­col­o­gy pipeline re­flect our com­mit­ment to ex­plor­ing a num­ber of new com­bi­na­tions with Keytru­da that we be­lieve could have a mean­ing­ful im­pact for more lung can­cer pa­tients,” Mer­ck Re­search Lab­o­ra­to­ries VP of on­col­o­gy clin­i­cal re­search Vic­ki Good­man said in a state­ment.

Cowen an­a­lysts pre­dict Keytru­da sales will reach $14.1 bil­lion in 2020, and $21.5 bil­lion in 2025.”How­ev­er, MRK’s in­creas­ing re­liance on this prod­uct, pos­si­bil­i­ty of sig­nif­i­cant M&A to di­ver­si­fy rev­enue, and lim­it­ed pipeline are risks,” they wrote in a re­port.

Back in May, Roche’s Tecen­triq got the FDA green light to treat new­ly di­ag­nosed, metasta­t­ic NSCLC pa­tients with­out EGFR or ALK mu­ta­tions whose tu­mors have high PD-L1 ex­pres­sion.

“By virtue of be­ing late to mar­ket, Tecen­triq monother­a­py (IM­POW­ER110) has lit­tle chance of gain­ing sig­nif­i­cant share in 1L NSCLC de­spite post­ing OS sim­i­lar to Keytru­da in PD-L1 high pa­tients,” Cowen an­a­lyst Steve Scala wrote in a note that month. “How­ev­er, that com­pa­ra­ble OS ben­e­fit may give con­fi­dence that any ad­di­tion­al ef­fi­ca­cy pro­vid­ed by (an­ti-TIG­IT drug) tiragolum­ab in Phase II will trans­late to su­pe­ri­or per­for­mance of the com­bi­na­tion in Phase III.”

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