In a stun­ner, Mer­ck leaps ahead of ri­vals with com­bo Keytru­da/chemo at­tack on lung can­cer

Mer­ck’s im­muno-on­col­o­gy team has be­come ex­pert at press­ing an ear­ly ad­van­tage.

The Keytru­da com­pa­ny, which re­cent­ly trounced Bris­tol-My­ers in their ri­val­ry on lung can­cer, has now filed an ear­ly and stun­ning ap­pli­ca­tion to mar­ket a com­bi­na­tion of Keytru­da and chemo for first-line lung can­cer. And the move has the po­ten­tial to carve out a short­cut that will al­low them to cut ahead of a strug­gling As­traZeneca and a po­tent Roche.

Mer­ck’s stock $MRK spiked close to 5% on the news of its lat­est ad­vance in the field as an­a­lysts pon­dered the im­pli­ca­tions in a field with block­buster po­ten­tial. Check­points alone treat on­ly a por­tion of all can­cer pa­tients, and a front­line com­bo could cap­ture the li­on’s share of the mar­ket.

The FDA ac­cept­ed the sup­ple­men­tal ap­pli­ca­tion and agreed to give the ap­pli­ca­tion a speedy re­view, of­fer­ing a de­ci­sion by May 10. And giv­en the agency’s go-go record on rush­ing ahead on promis­ing I/O ther­a­pies, Mer­ck may be on the verge of mak­ing an even ear­li­er break­through with its first com­bo ap­proach.

As­traZeneca ear­li­er re­tooled its im­muno-on­col­o­gy ef­fort for dur­val­um­ab, its all-im­por­tant check­point pro­gram, as it lagged be­hind the fron­trun­ners in the field. It’s now lin­ing up for the fourth or pos­si­bly fifth new ap­proval for a check­point, as it looks to en­ter a crowd­ed mar­ket in­volv­ing some of the most ag­gres­sive play­ers in the in­dus­try. And af­ter mul­ti­ple set­backs over the past year, the UK gi­ant can ill af­ford to con­tin­ue get­ting beat in I/O if it ever ex­pects to de­liv­er on am­bi­tious fore­casts of rev­enue growth.

As­traZeneca’s stock dropped 1% on the news.

Mer­ck’s play here is not with­out risk. Sea­mus Fer­nan­dez at Leerink not­ed:

MRK’s an­nounce­ment of the ac­cep­tance of an sBLA fil­ing for Keytru­da (pem­brolizum­ab) + chemother­a­py in first-line (1L) non-squa­mous non-small cell lung can­cer (NSCLC) re­gard­less of PD-L1 sta­tus comes as a sig­nif­i­cant sur­prise, po­ten­tial­ly es­tab­lish­ing Keytru­da as the first IO agent to be used broad­ly in non-squa­mous NSCLC re­gard­less of PDL1 sta­tus. FDA’s will­ing­ness to ac­cept the fil­ing based on such a small study (with no ev­i­dence of a sur­vival ben­e­fit in the da­ta pre­sent­ed at ES­MO) sug­gests to us that the agency may have vis­i­bil­i­ty in­to the like­li­hood of suc­cess on the PFS end­point in the on­go­ing Phase 3 Keynote-189 tri­al. If this com­bo re­ceives ac­cel­er­at­ed ap­proval by its PDU­FA date of 5/10/17, it like­ly would give MRK an­oth­er leg-up in the 1L NSCLC race over AZN (OP) and BMY’s (OP) IO+IO com­bos and RHH­BY’s (NR) IO+chemo com­bo. While we con­tin­ue to be­lieve that IO+IO com­bos will even­tu­al­ly pro­duce more durable re­spons­es (par­tic­u­lar­ly in pa­tients with high­er lev­els of PD-L1 ex­pres­sion), an ear­ly and broad ac­cel­er­at­ed ap­proval for this IO+chemo com­bo could fur­ther es­tab­lish Keytru­da as the PD-1 of choice in the 1L set­ting – at least un­til oth­er agents are ap­proved in this set­ting.

Roger Dansey, Mer­ck

Mer­ck has mount­ed hun­dreds of stud­ies around its Keytru­da fran­chise, of­ten part­ner­ing on po­ten­tial com­bos as the team mar­ries an im­mune sys­tem at­tack with com­ple­men­tary ther­a­pies.

Bris­tol-My­ers has al­so been la­bor­ing long and hard with Op­di­vo. But it’s ear­ly lead in the field was bad­ly dam­aged in 2016 as an over­ly am­bi­tious at­tempt to grab proof of ef­fi­ca­cy as a stand­alone lung can­cer drug end­ed in dis­as­ter.

Dr. Roger Dansey, se­nior vice pres­i­dent and ther­a­peu­tic area head, on­col­o­gy late-stage de­vel­op­ment, Mer­ck Re­search Lab­o­ra­to­ries, has this to say:

“Keytru­da in com­bi­na­tion with chemother­a­py has shown promise ver­sus chemother­a­py alone in the first-line treat­ment of non-squa­mous metasta­t­ic non-small cell lung can­cer, re­gard­less of PD-L1 lev­els. If ap­proved, this could be the first reg­i­men com­bin­ing chemother­a­py with an im­muno-on­col­o­gy agent for pa­tients with ad­vanced non-small cell lung can­cer.”

Oxitec biologist releases genetically modified mosquitoes in Piracicaba, Brazil in 2016 [credit: Getty Images]

In­trex­on unit push­es back against claims its GM mos­qui­toes are mak­ing dis­ease-friend­ly mu­tants

When the hysteria of Zika transmission sprang into the American zeitgeist a few years ago, UK-based Oxitec was already field-testing its male Aedes aegypti mosquito, crafted to possess a gene engineered to obliterate its progeny long before maturation.

But when a group of independent scientists evaluated the impact of the release of these genetically-modified mosquitoes in a trial conducted by Oxitec in Brazil between 2013 and 2015, they found that some of the offspring had managed to survive — prompting them to speculate what impact the survivors could have on disease transmission and/or insecticide resistance.

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Pur­due threat­ens to walk away from set­tle­ment, asks to pay em­ploy­ees mil­lions in bonus­es

There are two updates on the lawsuit against Purdue Pharma over its role in fueling the opioid epidemic, as the Sackler family threatens to walk away from their pledge to pay out $3 billion if a bankruptcy judge does not stop outstanding state lawsuits against them. At the same time, the company has asked permission to pay millions in bonuses to select employees.

Purdue filed for chapter 11 bankruptcy this week as part of its signed resolution to over 2,000 lawsuits. The deal would see the Sackler family that owns Purdue give $3 billion from their personal wealth and the company turned into a trust committed to curbing and reversing overdoses.

Aerial view of Genentech's campus in South San Francisco [Credit: Getty]

Genen­tech sub­mits a plan to near­ly dou­ble its South San Fran­cis­co foot­print

The sign is still there, a quaint reminder of whitewashed concrete not 5 miles from Genentech’s sprawling, chrome-and-glass campus: South Francisco The Industrial City. 

The city keeps the old sign, first erected in 1923, as a tourist site and a kind of civic memento to the days it packed meat, milled lumber and burned enough steel to earn the moniker “Smokestack of the Peninsula.” But the real indication of where you are and how much has changed both in San Francisco and in the global economy since a couple researchers and investors rented out an empty warehouse 40 years ago comes in a far smaller blue sign, resembling a Rotary Club post, off the highway: South San Francisco, The Birthplace of Biotech.

As Nas­daq en­rolls the fi­nal batch of 2019 IPOs, how have the num­bers com­pared to past years?

IGM Biosciences’ upsized IPO haul, coming after SpringWorks’ sizable public debut, has revved up some momentum for the last rush of biotech IPOs in 2019.

With 39 new listings on the books and roughly two more months to go before winding down, Nasdaq’s head of healthcare listings Jordan Saxe sees the exchange marking 50 to 60 biopharma IPOs for the year.

“December 15 is usually the last possible day that companies will price,” he said, as companies get ready for business talks at the annual JP Morgan Healthcare Conference in January.

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A fa­vorite in Alex­ion’s C-suite is leav­ing, and some mighty sur­prised an­a­lysts aren’t the least bit hap­py about it

Analysts hate to lose a biotech CFO they’ve come to trust and admire — especially if they’re being blindsided by a surprise exit.

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David Grainger [file photo]

'Dis­con­nect the bas­tard­s' — one biotech's plan to break can­cer cell­s' uni­fied de­fens­es

Chemotherapy and radiotherapy are the current gladiators of cancer treatment, but they come with well-known limitations and side-effects. The emergence of immunotherapy — a ferocious new titan in oncologist’s toolbox — takes the brakes off the immune system to kill cancer cells with remarkable success in some cases, but the approach is not always effective. What makes certain forms of cancer so resilient? Scientists may have finally pieced together a tantalizing piece of the puzzle, and a new biotech is banking on a new approach to fill the gap.

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While No­var­tis ban­ish­es Zol­gens­ma scan­dal scars — Bio­gen goes on a Spin­raza 'of­fen­sive'

While Novartis painstakingly works to mop up the stench of the data manipulation scandal associated with its expensive gene therapy for spinal muscular atrophy (SMA) Zolgensma— rival Biogen is attempting to expand the use of its SMA therapy, Spinraza. 

The US drugmaker $BIIB secured US approval for Spinraza for use in the often fatal genetic disease in 2016. The approval covered a broad range of patients with infantile-onset (most likely to develop Type 1) SMA. 

Jason Kelly. Mike Blake/Reuters via Adobe

Eye­ing big ther­a­peu­tic push, Gink­go bags $290M to build a cell pro­gram­ming em­pire

Ginkgo Bioworks is on a roll. Days after publicizing a plan to nurture new startups via partnerships with accelerators Y Combinator and Petri, the Boston biotech says it has raised another $290 million for its cell programming platform to reach further and wider.

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UP­DAT­ED: Speak­er Nan­cy Pelosi to un­veil bill for fed­er­al­ly ne­go­ti­at­ed drug prices

After months of buzz from both sides of the aisle, Speaker Nancy Pelosi will today introduce her plan to allow the federal government to negotiate prices for 250 prescription drugs, setting up a showdown with a pharmaceutical industry working overtime to prevent it.

The need to limit drug prices is a rare point of agreement between President Trump and Democrats, although the president has yet to comment on the proposal and will likely face pressure to back a more conservative option or no bill at all. Republican Senator Chuck Grassley is reportedly lobbying his fellow party members on a more modest proposal he negotiated with Democratic Senator Ron Wyden in July.