#AACR: Mer­ck spot­lights piv­otal Keytru­da/chemo da­ta, hop­ing to break down skep­ti­cism to its front­line lung can­cer duo

CHICA­GO — Mer­ck wowed the im­muno-on­col­o­gy mar­ket ear­ly this year with the head­line news that its piv­otal KEYNOTE-189 study demon­strat­ed a clear suc­cess for Keytru­da com­bined with chemo in treat­ing front­line lung can­cer cas­es. And at AACR in Chica­go to­day, its in­ves­ti­ga­tors spelled out the promis­ing re­sults — demon­strat­ing that the com­bo re­duced the risk of death by half with a haz­ard ra­tio of 0.49 — as Mer­ck looks to hold back a wave of ma­jor league com­peti­tors as it carves out a big­ger share of the block­buster lung can­cer mar­ket.

In the first look at hard da­ta for non­squa­mous non-small cell lung can­cer — which will be care­ful­ly com­pared with the da­ta from Bris­tol-My­ers — re­searchers say that their com­bo clear­ly beat out chemo alone on over­all sur­vival, though the fi­nal OS rate for the com­bi­na­tion has not yet been reached. 

Leena Gand­hi

The great­est ben­e­fit among these pa­tients was among the high PD-L1 ex­pressers, but chief in­ves­ti­ga­tor Leena Gand­hi at the Perl­mut­ter Can­cer Cen­ter at NYU Lan­gone Health al­so says that the sur­vival ben­e­fit could be seen across the board on PD-L1 ex­pres­sion.

Mer­ck’s piv­otal da­ta from the -189 study are cru­cial to their cam­paign to be the leader in check­point in­hi­bi­tion. Ap­proved by the FDA for front­line cas­es on Phase II da­ta — but re­ject­ed in Eu­rope — Mer­ck says that physi­cians have been slow to change the way they treat lung can­cer. Now Mer­ck be­lieves this da­ta should re­solve any doubts as Keytru­da be­comes the stan­dard of care in this crit­i­cal­ly im­por­tant set­ting.

At 12 months, Gand­hi tells me, 69.2% of the com­bo arm was still alive, com­pared to 49.4% in the con­trol arm. 

Ac­cord­ing to Mer­ck, pa­tients in the drug arm were 51% less like­ly to die than the con­trol group, and those in the high­est PD-L1 score group were 58% less like­ly to die. The rates held up de­spite a high num­ber of pa­tients who crossed over to the com­bo af­ter their dis­ease pro­gressed.

“The great­est ben­e­fit was seen in those with high lev­els of PD-L1 ex­pres­sion, sug­gest­ing that PD-L1 does have some pre­dic­tive val­ue even in this com­bi­na­tion set­ting,” Gand­hi said. 

Me­di­an PFS was 8.8 months for the pem­brolizum­ab arm, ver­sus 4.9 months for the con­trol group.

Some an­a­lysts have been wait­ing to see if the ben­e­fits for the com­bo leaned pri­mar­i­ly to high PD-L1 ex­pressers, leav­ing ri­vals an open­ing in divvy­ing up the mar­ket on the rest. But Gand­hi says the sur­vival ad­van­tages are clear re­gard­less of PD-L1 sta­tus. That marks a trend that many are see­ing, where new ther­a­peu­tic ap­proach­es are de­liv­er­ing en­hanced re­sults for the high-PD-L1 group while re­tain­ing promis­ing re­sults for the full field.

“There was no group that didn’t get a sur­vival ben­e­fit in this study,” Gand­hi says, with the re­sults of­fer­ing a prac­tice-chang­ing set of re­sults. She al­so says she wants to ful­ly con­sid­er the fi­nal da­ta from Check­mate-227 (Bris­tol-My­ers) and IM­pow­er-150 (Roche) as she pon­ders the chang­ing scene for prac­ti­tion­ers.

John Reed at JPM 2019. Jeff Rumans for Endpoints News

Sanofi's John Reed con­tin­ues to re­or­ga­nize R&D, cut­ting 466 jobs while boost­ing can­cer, gene ther­a­py re­search

The R&D reorganization inside Sanofi is continuing, more than a year after the pharma giant brought in John Reed to head the research arm of the Paris-based company.
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The top 10 block­buster drugs in the late-stage pipeline — Eval­u­ate adds 6 new ther­a­pies to heavy-hit­ter list

Vertex comes in for a substantial amount of criticism for its no-holds-barred tactical approach toward wresting the price it wants for its commercial drugs in Europe. But the flip side of that coin is a highly admired R&D and commercial operation that regularly wins kudos from analysts for their ability to engineer greater cash flow from the breakthrough drugs they create.

Both aspects needed for success in this business are on display in the program backing Vertex’s triple for cystic fibrosis. VX-659/VX-445 + Tezacaftor + Ivacaftor — it’s been whittled down to 445 now — was singled out by Evaluate Pharma as the late-stage therapy most likely to win the crown for drug sales in 5 years, with a projected peak revenue forecast of $4.3 billion.

The latest annual list, which you can see here in their latest world preview, includes a roster of some of the most closely watched development programs in biopharma. And Evaluate has added 6 must-watch experimental drugs to the top 10 as drugs fail or go on to a first approval. With apologies to the list maker, I revamped this to rank the top 10 by projected 2024 sales, instead of Evaluate's net present value rankings.

It's how we roll at Endpoints News.

Here is a quick summary of the rest of the top 10:

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Neil Woodford. Woodford Investment Management via YouTube

Wood­ford braces po­lit­i­cal storm as UK fi­nan­cial reg­u­la­tors scru­ti­nize fund sus­pen­sion

The shock of Neil Wood­ford’s de­ci­sion to block with­drawals for his flag­ship fund is still rip­pling through the rest of his port­fo­lio — and be­yond. Un­der po­lit­i­cal pres­sure, UK fi­nan­cial reg­u­la­tors are now tak­ing a hard look while in­vestors con­tin­ue to flee.

In a re­sponse let­ter to an MP, the Fi­nan­cial Con­duct Au­thor­i­ty re­vealed that it’s opened an in­ves­ti­ga­tion in­to the sus­pen­sion fol­low­ing months of en­gage­ment with Link Fund So­lu­tions, which tech­ni­cal­ly del­e­gat­ed Wood­ford’s firm to man­age its funds.

Gilead baits new al­liance with $45M up­front, div­ing in­to the busy pro­tein degra­da­tion field

Gilead is jump­ing on board the pro­tein degra­da­tion band­wag­on. And they’re turn­ing to a low-pro­file Third Rock start­up for the ex­per­tise. But if you were look­ing for a trans­for­ma­tion­al deal to kick up fresh en­thu­si­asm for Gilead, you’ll have to re­main pa­tient.

This one will have a long way to go be­fore they get in­to the clin­ic.

The big biotech said Wednes­day morn­ing that it is pay­ing $45 mil­lion up­front and re­serv­ing a whop­ping $2.3 bil­lion in biotech bucks if San Fran­cis­co-based Nurix can point the way to new can­cer ther­a­pies, as well as drugs for oth­er, un­spec­i­fied dis­eases.

A new num­ber 1 drug? Keytru­da tapped to top the 10 biggest block­busters on the world stage by 2024

Analysts may be fretting about Keytruda’s longterm prospects as a host of rival therapies elbow their way to the market. But the folks at Evaluate Pharma are confident that last year’s $7 billion earner is headed for glory, tapping it to beat out the current #1 therapy Humira as AbbVie watches that franchise swoon over the next 5 years.

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In­vestor day prep at Mer­ck in­cludes a new strat­e­gy to pick up the pace on M&A — re­port

Mer­ck’s re­cent deals to buy up two bolt-on biotechs — Ti­los and Pelo­ton — weren’t an aber­ra­tion. In­stead, both ac­qui­si­tions mark a new strat­e­gy to beef up its dom­i­nant can­cer drug op­er­a­tions cen­tered on Keytru­da while look­ing to ad­dress grow­ing con­cerns that too many of its eggs are in the one I/O bas­ket for their PD-1 pro­gram. And Mer­ck is go­ing af­ter more small- and mid-sized buy­outs to calm those fears.

John Chiminski, Catalent CEO - File Photo

'It's a growth play': Catal­ent ac­quires Bris­tol-My­er­s' Eu­ro­pean launch pad, ex­pand­ing glob­al CD­MO ops

Catalent is staying on the growth track.

Just two months after committing $1.2 billion to pick up Paragon and take a deep dive into the sizzling hot gene therapy manufacturing sector, the CDMO is bouncing right back with a deal to buy out Bristol-Myers’ central launchpad for new therapies in Europe, acquiring a complex in Anagni, Italy, southwest of Rome, that will significantly expand its capacity on the continent.

There are no terms being offered, but this is no small deal. The Anagni campus employs some 700 staffers, and Catalent is planning to go right in — once the deal closes late this year — with a blueprint to build up the operations further as they expand on oral solid, biologics, and sterile product manufacturing and packaging.

This is an uncommon deal, Catalent CEO John Chiminski tells me. But it offers a shortcut for rapid growth that cuts years out of developing a green fields project. That’s time Catalent doesn’t have as the industry undergoes unprecedented expansion around the world.

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Arc­turus ex­pands col­lab­o­ra­tion, adding $30M cash; Ku­ra shoots for $100M raise

→  Rare dis­ease play­er Ul­tragenyx $RARE is ex­pand­ing its al­liance with Arc­turus $ARCT, pay­ing $24 mil­lion for eq­ui­ty and an­oth­er $6 mil­lion in an up­front as the two part­ners ex­pand their col­lab­o­ra­tion to in­clude up to 12 tar­gets. “This ex­pand­ed col­lab­o­ra­tion fur­ther so­lid­i­fies our mR­NA plat­form by adding ad­di­tion­al tar­gets and ex­pand­ing our abil­i­ty to po­ten­tial­ly treat more dis­eases,” said Emil Kakkis, the CEO at Ul­tragenyx. “We are pleased with the progress of our on­go­ing col­lab­o­ra­tion. Our most ad­vanced mR­NA pro­gram, UX053 for the treat­ment of Glyco­gen Stor­age Dis­ease Type III, is ex­pect­ed to move in­to the clin­ic next year, and we look for­ward to fur­ther build­ing up­on the ini­tial suc­cess of this part­ner­ship.”

UP­DAT­ED: Chica­go biotech ar­gues blue­bird, Third Rock 'killed' its ri­val, pi­o­neer­ing tha­lassemia gene ther­a­py in law­suit

Blue­bird bio $BLUE chief Nick Leschly court­ed con­tro­ver­sy last week when he re­vealed the com­pa­ny’s be­ta tha­lassemia treat­ment will car­ry a jaw-drop­ping $1.8 mil­lion price tag over a 5-year pe­ri­od in Eu­rope — mak­ing it the plan­et’s sec­ond most ex­pen­sive ther­a­py be­hind No­var­tis’ $NVS fresh­ly ap­proved spinal mus­cu­lar at­ro­phy ther­a­py, Zol­gens­ma, at $2.1 mil­lion. A Chica­go biotech, mean­while, has been fum­ing at the side­lines. In a law­suit filed ear­li­er this month, Er­rant Gene Ther­a­peu­tics al­leged that blue­bird and ven­ture cap­i­tal group Third Rock un­law­ful­ly prised a vi­ral vec­tor, de­vel­oped in part­ner­ship with the Memo­r­i­al Sloan Ket­ter­ing Can­cer Cen­ter (MSK), from its grasp, and thwart­ed the de­vel­op­ment of its sem­i­nal gene ther­a­py.