#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.

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

FDA chief Stephen Hahn on Capitol Hill earlier this week (Getty Images)

As FDA buck­les un­der the strain of a pan­dem­ic work­load, Trump again ac­cus­es the agency of a po­lit­i­cal hit job

Peter Marks appeared before a virtual SVB Leerink audience yesterday and said that his staff at FDA’s CBER is on the verge of working around the clock. Manufacturing inspections, policy work and sponsor communications have all been pushed down the to-do list so that they can be responsive to Covid-related interactions. And the agency’s objective right now? “To save as many lives as we can,” Marks said, likening the mortality on the current outbreak as equivalent to “a nuclear bomb on a small city.”

Daniel O'Day, Gilead CEO (Kevin Dietsch/UPI/Bloomberg via Getty Images)

Play-by-play of Gilead­'s $21B Im­munomedics buy­out de­tails a fren­zied push — and mints a new biotech bil­lion­aire

Immunomedics had not really been looking for a buyout when the year began. Excited by its BLA for Trodelvy, submitted to the FDA in late 2019, executive chairman Behzad Aghazadeh started off looking for potential licensing deals and zeroed in on four potential partners, including Gilead, following January’s JP Morgan Healthcare Conference in San Francisco. Such talks advanced throughout the year, with discussions advancing to the second round in mid-August.

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The win­dow is wide open as four more biotechs join the go-go IPO class of 2020

It’s another day of hauling cash in the biopharma world as four more IPOs priced Friday and a fifth filed its initial paperwork.

The biggest offering comes from PMV Pharma, an oncology biotech focusing on p53 mutations, which raised $211.8 million after pricing shares at $18 apiece. Prelude Therapeutics, developing PRMT5 inhibitors for rare cancers, was next with a $158 million raise, pricing shares at $19 each. Graybug Vision raised $90 million after pricing at $16 per share for its wet AMD candidates, and breast cancer biotech Greenwich Lifesciences brought up the rear with a small, $7 million raise after pricing shares at $5.75.

J&J of­fers PhI/IIa da­ta show­ing its sin­gle-dose vac­cine can stir up suf­fi­cient im­mune re­sponse

Days after J&J dosed the first participants of its Phase III ENSEMBLE trial, the pharma giant has detailed the early-stage data that gave them confidence in a single-dose regimen.

Testing two dose levels either as a single dose or in a two-dose schedule spaced by 56 days in, the scientists from Janssen, the J&J subsidiary developing its vaccine, reported that the low dose induced a similar immune response as the high dose. The interim Phase I/IIa results were posted in a preprint on medRxiv.

President Donald Trump reacts after signing an executive order following his remarks on his healthcare policies yesterday in Charlotte, North Carolina (Getty Images)

Op-ed: Will phar­ma re­al­ly pay for Trump’s lat­est law­less promise to 33 mil­lion Medicare ben­e­fi­cia­ries? Not like­ly

Sitting atop the executive branch, President Donald Trump is the ultimate authority at the FDA. He can fast track any vaccine to approval himself. If it came to that, of course.

What he can’t do is unilaterally order the legislative branch to loosen the Treasury’s coffers for $6.6 billion. Nor can he command pharmaceutical companies to pay for $200 vouchers sent to 33 million Medicare beneficiaries for prescription drugs before the election.

Pal­la­dio bags $20 mil­lion Se­ries B to top­ple a prob­lem­at­ic kid­ney dis­ease drug

Palladio Biosciences just took one step further in its quest to topple Otsuka’s Samsca with its own — it hopes safer — autosomal dominant polycystic kidney disease (ADPKD) drug.

The Pennsylvania-based biotech announced a $20 million Series B on Friday, which will fund a 10-person Phase III trial of its vasopressin V2 receptor agonist, lixivaptan. CEO Alex Martin expects to read out data in the first half of next year, then launch straight into a larger pivotal Phase III study with about 1,200 participants.

New York governor Andrew Cuomo (AP Images)

An­drew Cuo­mo says New York will un­der­take its own vac­cine re­view process, and wouldn’t rec­om­mend trust­ing the fed­er­al gov­ern­ment

The concerns keep mounting over President Donald Trump’s politicization of the FDA and other federal agencies guiding the development of a safe and effective vaccine. And today, the telegenic New York governor Andrew Cuomo appeared to introduce even more politics into the matter — latest in an ongoing series of incidents that have cast the proudly independent FDA in starkly political terms.

During his daily press conference Cuomo said that the state will review any coronavirus vaccines approved by the federal government, citing a lack of trust in the Trump administration. The announcement comes one day after Trump accused the FDA of making an “extremely political” move in proposing stricter vaccine guidance.

PhII Alzheimer's fail­ure deals new blow to Roche, AC Im­mune — but the tau hy­poth­e­sis is far from dead

The leading anti-tau antibody has failed its first Phase II testing, casting a shadow on a popular target (just trailing amyloid beta) for Alzheimer’s disease.

Roche and AC Immune are quick to acknowledge disappointment in the topline readout, which suggested that semorinemab did not reduce cognitive decline among patients with early Alzheimer’s disease, who are either just starting to have symptoms or have mild manifestations.

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