Best in class? Eli Lil­ly claims a lead role awaits its CDK 4/6 drug abe­maci­clib af­ter PhI­II suc­cess

Levi Gar­raway, Lil­ly

The phar­ma gi­ant says their drug abe­maci­clib gar­nered promis­ing da­ta in an in­ter­im analy­sis of MONARCH-3, a breast can­cer tri­al that matched their drug with ei­ther of two aro­matase in­hibitors — letro­zole or anas­tro­zole — against on­ly the aro­matase in­hibitor. The full da­ta will be rolled out lat­er, with Lil­ly lim­it­ing it­self to the boast that their drug has the po­ten­tial to be the best-in-class ther­a­py in the like­ly three-way strug­gle to come.

In­ves­ti­ga­tors re­cruit­ed women with hor­mone-re­cep­tor-pos­i­tive, hu­man epi­der­mal growth fac­tor re­cep­tor 2-neg­a­tive (HER2-) ad­vanced breast can­cer.

Lil­ly had dropped well be­hind the two fron­trun­ners with their broad and am­bi­tious Phase III pro­gram. MONARCH 1 and MONARCH 2 da­ta are be­ing teed up to reg­u­la­tors at the FDA and EMA in this quar­ter, with the MONARCH 3 pack­age be­ing prepped for a Q3 de­liv­ery.

Lil­ly is rac­ing to catch up with No­var­tis, which gained an ap­proval for Kisqali (ri­bo­ci­clib) in March. And Pfiz­er scored the land­mark ap­proval in the field with Ibrance in 2015, help­ing that com­pa­ny achieve a not­ed ad­vance in can­cer drug R&D.

The pri­ma­ry end­point of the Lil­ly study was PFS, with key sec­ondary end­points of ORR, over­all sur­vival and safe­ty. And Sea­mus Fer­nan­dez at Lil­ly was pleas­ant­ly sur­prised by the in­ter­im suc­cess — par­tic­u­lar­ly as an ear­li­er tri­al had to run its full course be­fore Lil­ly could claim a win.

This is an un­ex­pect­ed win for LLY, in our view, as we and most in­vestors ex­pect­ed the tri­al to go to com­ple­tion at its planned fi­nal analy­sis at the end of this year.

An­a­lysts will be look­ing for the ac­tu­al da­ta to see how it mea­sures up with ri­vals, par­tic­u­lar­ly af­ter Lil­ly man­aged to stun the bio­phar­ma world with news that the FDA had re­ject­ed baric­i­tinib, wide­ly ex­pect­ed to breeze through to an OK. Lil­ly has yet to ex­plain what went wrong, which is not help­ing its R&D cred­i­bil­i­ty af­ter three straight fail­ures for its lead Alzheimer’s drug solanezum­ab.

“To­day marks an­oth­er im­por­tant mile­stone in our clin­i­cal de­vel­op­ment pro­gram for abe­maci­clib, a drug we be­lieve has the po­ten­tial to be best in class,” said Levi Gar­raway, se­nior vice pres­i­dent, glob­al de­vel­op­ment and med­ical af­fairs, Lil­ly On­col­o­gy. “We are very ex­cit­ed about the re­sults seen in pa­tients with breast can­cer, from sin­gle-agent ac­tiv­i­ty to clin­i­cal­ly mean­ing­ful ben­e­fit when used in com­bi­na­tion with ful­ves­trant or aro­matase in­hibitors. Along with ad­di­tion­al abe­maci­clib clin­i­cal tri­als in oth­er tu­mor types, these da­ta un­der­score Lil­ly’s com­mit­ment to de­liv­er­ing life-chang­ing med­i­cines to treat and cure peo­ple liv­ing with can­cer around the world.”

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.

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

Al­ny­lam gets the green light 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.

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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In fi­nal days at Mer­ck, Roger Perl­mut­ter bets big on a lit­tle-known Covid-19 treat­ment

Roger Perlmutter is spending his last days at Merck, well, spending.

Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

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Pascal Soriot (AP Images)

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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Bahija Jallal (file photo)

TCR pi­o­neer Im­muno­core scores a first with a land­mark PhI­II snap­shot on over­all sur­vival for a rare melanoma

Bahija Jallal’s crew at TCR pioneer Immunocore says they have nailed down a promising set of pivotal data for their lead drug in a frontline setting for a solid tumor. And they are framing this early interim readout as the convincing snapshot they need to prove that their platform can deliver on a string of breakthrough therapies now in the clinic or planned for it.

In advance of the Monday announcement, Jallal and R&D chief David Berman took some time to walk me through the first round of Phase III data for their lead TCR designed to treat rare, frontline cases of metastatic uveal melanoma that come with a grim set of survival expectations.

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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.

Carl Hansen, AbCellera CEO (University of British Columbia)

From a pair of Air Jor­dans to a $200M-plus IPO, Carl Hansen is craft­ing an overnight R&D for­tune fu­eled by Covid-19

Back in the summer of 2019, Carl Hansen left his post as a professor at the University of British Columbia to go full time as the CEO at a low-profile antibody shop he had founded called AbCellera.

As biotech CEOs go, even after a fundraise Hansen wasn’t paid a whole heck of a lot. He ended up earning right at $250,000 for the year. His compensation package included a loan — which he later paid back — and a pair of Air Jordan tennis shoes. His newly-hired CFO, Andrew Booth, got a sweeter pay packet than that — which included his own pair of Air Jordans.

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Leonard Schleifer, Regeneron CEO (Andrew Harnik/AP)

Trail­ing Eli Lil­ly by 12 days, Re­gen­eron gets the FDA OK for their Covid-19 an­ti­body cock­tail

A month and a half after becoming the experimental treatment of choice for a newly diagnosed president, Regeneron’s antibody cocktail has received emergency use authorization from the FDA. It will be used to treat non-hospitalized Covid-19 patients who are at high-risk of progressing.

Although the Rgeneron drug is not the first antibody treatment authorized by the FDA, the news comes as a significant milestone for a company and a treatment scientists have watched closely since the outbreak began.