Mer­ck, In­cyte map a Phase III pipeline of their own for a front­line com­bo of Keytru­da and epaca­do­stat

Keytru­da (pem­brolizum­ab)

Last fall In­cyte and Mer­ck whipped up con­sid­er­able en­thu­si­asm for a match-up of their IDO1 en­zyme in­hibitor and Keytru­da in an ear­ly-stage study of melanoma. They fol­lowed up with a com­mit­ment to ex­pand their part­ner­ship to go af­ter a range of can­cers. And this morn­ing the part­ners out­lined ag­gres­sive plans to take the com­bo through sev­en piv­otal tri­als.

Re­searchers for these two com­pa­nies got ex­cit­ed about the po­ten­tial for this com­bi­na­tion af­ter see­ing pro­gres­sion-free sur­vival rates of 74 per­cent and 57 per­cent at 6 months and 12 months among the ad­vanced melanoma pa­tients they treat­ed last year in a Phase I. Their melanoma part­ner­ship was ex­pand­ed to in­clude a Phase III melanoma tri­al. Now they are push­ing ahead in the clin­ic to see if In­cyte’s epaca­do­stat and Keytru­da can make a sig­nif­i­cant dif­fer­ence in front­line use against non-small cell lung can­cer, blad­der can­cer, re­nal can­cer and squa­mous cell car­ci­no­ma of the head and neck (SC­CHN).

Al­ready in a Phase III melanoma study, in­ves­ti­ga­tors are adding:

• Two Phase III stud­ies in first-line NSCLC, in­clud­ing both PD-L1 high-ex­press­ing and PD-L1 un­s­e­lect­ed pop­u­la­tions.
• Two Phase III stud­ies in blad­der can­cer, in­clud­ing one in first-line blad­der can­cer and one in sec­ond-line blad­der can­cer.
• A Phase III study in first-line RCC.
• And a Phase III study in first-line SC­CHN.

Mer­ck is man­ag­ing the tri­al work while the two com­pa­nies share ex­pens­es.

When RBC’s Simos Sime­oni­dis saw the first cut of the Phase I da­ta, he con­clud­ed that In­cyte and Mer­ck have an ex­cel­lent shot of beat­ing out Bris­tol-My­ers Squibb’s piv­otal com­bi­na­tion study of Yer­voy and Op­di­vo for first-line use in non-small cell lung can­cer. And right now, Mer­ck’s abil­i­ty to ma­neu­ver past Bris­tol-My­ers and seize the lead on NSCLC con­tin­ues to stag­ger an­a­lysts.

Mer­ck, of course, is spar­ing no ex­pense in push­ing dozens of piv­otal stud­ies of Keytru­da, in­tent on cap­i­tal­iz­ing on a ma­jor mar­ket op­por­tu­ni­ty and un­will­ing to let a grow­ing field of com­peti­tors ham­per its pur­suit of block­buster rev­enue.

Most re­cent­ly Pfiz­er and Mer­ck KGaA gained an ap­proval for the fourth check­point ther­a­py — com­ing in right be­hind Roche — which un­leash­es an im­mune sys­tem at­tack on can­cer cells. As­traZeneca, mean­while, re­jigged its de­vel­op­ment ef­fort to amp up its work on a com­bi­na­tion of dur­val­um­ab and treme­li­mum­ab.

Ri­vals in the field are pay­ing rapt at­ten­tion to every new move.

Im­ple­ment­ing re­silience in the clin­i­cal tri­al sup­ply chain

Since January 2020, the clinical trials ecosystem has quickly evolved to manage roadblocks impeding clinical trial integrity, and patient care and safety amid a global pandemic. Closed borders, reduced air traffic and delayed or canceled flights disrupted global distribution, revealing how flexible logistics and supply chains can secure the timely delivery of clinical drug products and therapies to sites and patients.

Vas Narasimhan, Novartis CEO (Jason Alden/Bloomberg via Getty Images)

Vas Narasimhan's 'Wild Card' drugs: No­var­tis CEO high­lights po­ten­tial jack­pots, as well as late-stage stars, in R&D pre­sen­ta­tion

Novartis is always one of the industry’s biggest R&D spenders. As they often do toward the end of each year, company execs are highlighting the drugs they expect will most likely be winners in 2021.

And they’re also dreaming about some potential big-time lottery tickets.

As part of its annual investor presentation Tuesday, where the company allows investors and analysts to virtually schmooze with the bigwigs, Novartis CEO Vas Narasimhan will outline what he thinks are the pharma’s “Wild Cards.” The slate of five experimental drugs are those that Novartis hopes can be high-risk, high-reward entrants into the market over the next half-decade or so, and cover a wide range of indications.

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UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Gen­mab ax­es an ADC de­vel­op­ment pro­gram af­ter the da­ta fail to im­press

Genmab $GMAB has opted to ax one of its antibody-drug conjugates after watching it flop in the clinic.

The Danish biotech reported Tuesday that it decided to kill their program for enapotamab vedotin after the data gathered from expansion cohorts failed to measure up. According to the company:

While enapotamab vedotin has shown some evidence of clinical activity, this was not optimized by different dose schedules and/or predictive biomarkers. Accordingly, the data from the expansion cohorts did not meet Genmab’s stringent criteria for proof-of-concept.

The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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Pur­due Phar­ma pleads guilty in fed­er­al Oxy­Con­tin probe, for­mal­ly rec­og­niz­ing it played a part in the opi­oid cri­sis

Purdue Pharma, the producer of the prescription painkiller OxyContin, admitted Tuesday that, yes, it did contribute to America’s opioid epidemic.

The drugmaker formally pleaded guilty to three criminal charges, the AP reported, including getting in the way of the DEA’s efforts to combat the crisis, failing to prevent the painkillers from ending up on the black market and encouraging doctors to write more painkiller prescriptions through two methods: paying them in a speakers program and directing a medical records company to send them certain patient information. Purdue’s plea deal calls for $8.3 billion in criminal fines and penalties, but the company is only liable for a fraction of that total — $225 million.

John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

UP­DAT­ED: Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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Bob Nelsen (Photo by Michael Kovac/Getty Images)

Bob Nelsen rais­es $800M and re­cruits a star-stud­ded board to build the 'Fox­con­n' of biotech

Bob Nelsen spent his pandemic spring in his Seattle home, talking on the phone with Luciana Borio, the scientist who used to run pandemic preparedness on the National Security Council, and fuming with her about the dire state of American manufacturing.

Companies were rushing to develop vaccines and antibodies for the new virus, but even if they succeeded, there was no immediate supply chain or infrastructure to mass-produce them in a way that could make a dent in the outbreak.

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Am­gen sev­ers 14-year Cy­to­ki­net­ics part­ner­ship, bail­ing on ome­cam­tiv af­ter mixed PhI­II re­sults

Amgen is shrugging off a 14-year development alliance and the tens of millions of dollars spent to develop a new heart drug at Cytokinetics after a Phase III trial turned up weak data — leaving Cytokinetics to soldier on alone.

Omecamtiv mecarbil technically worked, meeting the primary composite endpoint in the Phase III GALACTIC-HF study. But it missed a key secondary endpoint, which analysts had been following as a key marker for success — reduction of cardiovascular (CV) death. While Cytokinetics celebrated the results, its stock tanked 43% upon the news, and analysts warned of an uncertain path ahead. Now, Amgen wants out.