#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.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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Michael Corbo, Pfizer CDO of inflammation & immunology

UP­DAT­ED: Plan­ning ahead for crowd­ed ul­cer­a­tive col­i­tis mar­ket, Pfiz­er spells out PhI­II da­ta on $6.7B Are­na drug

Pfizer has laid out the detailed results behind its boast that etrasimod — the S1P receptor modulator at the center of its $6.7 billion buyout of Arena Pharma — is the winner of the class, potentially leapfrogging an earlier entrant from Bristol Myers Squibb.

Pivotal data from the ELEVATE program in ulcerative colitis — which consists of two Phase III trials, one lasting 52 weeks and the other just 12 weeks — illustrate an “encouraging balance of efficacy and safety,” according to Michael Corbo, chief development officer of inflammation & immunology at Pfizer. The company is presenting the results as a late breaker at Digestive Disease Week.

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An NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

'Xeno­trans­plan­ta­tion is com­ing': New NE­JM pa­per gives de­tailed look in­to 2 pig-to-hu­man kid­ney trans­plant cas­es

The thymokidney is a curious organ, if you could call it that. It’s a sort of Frankensteinian creation — a system of pig thymus embedded underneath the outer layer of a pig’s kidney, made for human transplantation.

In the first case of pig-to-human xenotransplantation of a kidney into a brain-dead patient, the thymokidney quietly featured front and center.

In that experiment, which took place in September of last year, NYU researchers led by Robert Montgomery sutured a pig thymokidney onto the leg of a brain-dead 66-year-old woman. That case was widely reported on by a horde of major media outlets, including the New York Times, the BBC, and an in-depth feature by USA Today.

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Vlad Coric, Biohaven CEO

UP­DAT­ED: Fresh off $11.6B sale to Pfiz­er, New Bio­haven hits Phase III set­back just weeks af­ter Vlad Coric chalked up promise

When Pfizer bought up Biohaven’s migraine portfolio in the largest M&A deal of the year earlier this month, Biohaven CEO Vlad Coric promised the rest of the pipeline, which will live on under the umbrella of New Biohaven, still has a lot to offer. But that vision took a dent Monday as the drugmaker revealed it’s once again flopped on troriluzole.

The glutamate regulator failed to meet the primary endpoint on a Phase III study in patients with spinocerebellar ataxia, an inherited disorder that impairs a person’s ability to walk, speak and swallow. SCA can also lead to premature death.

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Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Phar­ma com­pa­ny con­tin­ues its FDA law­suit spree, this time af­ter agency de­nies fast-track des­ig­na­tion

Vanda Pharmaceuticals is making a name for itself, at least in terms of suing the FDA.

The DC-headquartered firm on Monday filed its latest suit against the agency, with the company raising concerns over the FDA’s failure to grant a fast track designation for Vanda’s potential chronic digestive disorder drug tradipitant, which is a neurokinin 1 receptor antagonist.

Specifically, Vanda said FDA’s “essential point” in its one-page denial letter on the designation pointed to “the lack of necessary safety data,” which was “inconsistent with the criteria for … Fast Track designation.”

Mod­er­na seeks to dis­miss Al­ny­lam suit over Covid-19 vac­cine com­po­nent, claim­ing wrong venue

RNAi therapeutics juggernaut Alnylam Pharmaceuticals made a splash in March when it sued and sought money from both Pfizer and Moderna regarding their use of Alnylam’s biodegradable lipids, which Alnylam claims have been integral to the way both companies’ mRNA-based Covid-19 vaccines work.

But now, Moderna lawyers are firing back, telling the same Delaware district court that Alnylam’s claims can only proceed against the US government in the Court of Federal Claims because of the way the company’s contract is set up with the US government. The US has spent almost $10 billion on Moderna’s Covid-19 vaccine so far.

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(Credit: Shutterstock)

Cracks in the fa­cade: Is phar­ma's pan­dem­ic ‘feel good fac­tor’ wan­ing?

The discordant effects of the Covid-19 pandemic on pharma reputation continues. While the overall industry still retains a respectable halo from its Covid-19 quick response and leadership, a new patient group study reveals a different story emerging in the details.

On one hand, US patient advocacy groups rated the industry higher-than-ever overall. More than two-thirds (67%) of groups gave the industry a thumbs up for 2021, a whopping 10 percentage point increase over the year before, according to the PatientView annual study, now in its 9th year.

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Saqib Islam, SpringWorks CEO

Pfiz­er spin­out Spring­Works will ship its first drug to the FDA be­fore year’s end with PhI­II win

SpringWorks Therapeutics thinks it has cemented the backbone for its first “pipeline-in-a-product” oncology treatment and will send it to the FDA before the clock strikes 2023 with a Phase III win on Tuesday.

The oral gamma secretase inhibitor, dubbed nirogacestat, beat placebo on the primary goal of progression-free survival in adults with progressing desmoid tumors.

The soft-tissue tumors can lead to long-lasting pain, disfigurement and amputation, and there are currently no approved meds for the rare oncology indication. The tumors typically impact patients aged 20 to 44 years old and disproportionately affect women at rates 2 to 3 times higher, with up to a total of 1,650 new cases diagnosed in the US annually, according to SpringWorks.

Robert Califf (Michael Brochstein/Sipa USA via AP Images)

House Re­pub­li­cans at­tack Chi­na-on­ly da­ta in FDA sub­mis­sions, seek new in­ves­ti­ga­tion in­to re­search in­spec­tions

Three Republican representatives are calling on the FDA to take a closer look at the applications including only clinical data from China.

The letter to FDA commissioner Rob Califf late last week comes as the agency recently rejected Eli Lilly’s anti-PD-1 antibody, which attempted to bring China-only data but ran into a bruising adcomm that may crush the hopes of any other companies looking to bring cheaper follow-ons based only on Chinese data.

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