As­traZeneca gets a green light on Imfinzi for small-cell lung can­cer — set­ting the stage for a bat­tle with Roche's Tecen­triq

The stan­dard-of-care for small-cell lung can­cer (SCLC) for decades was plat­inum-based chemother­a­py, but that par­a­digm shift­ed in 2018, with the ap­proval of Bris­tol My­ers Squibb’s check­point in­hibitor Op­di­vo in the sec­ond-line set­ting. Since then, a slate of im­munother­a­pies have se­cured SCLC ap­provals, and the lat­est is As­traZeneca’s flag­ship Imfinzi, which was ap­proved on Mon­day in com­bi­na­tion with stan­dard chemother­a­py as the first line of de­fense in ex­ten­sive-stage SCLC pa­tients.

The ap­proval was based on the re­sults of the late-stage, 805 pa­tient-CASPI­AN tri­al, which test­ed Imfinzi plus stan­dard-of-care chemother­a­py, or Imfinzi and chemother­a­py with the ad­di­tion of As­traZeneca’s in-house CT­LA-4 drug treme­li­mum­ab, ver­sus chemother­a­py alone.

The pri­ma­ry end­point was over­all sur­vival in each of the two ex­per­i­men­tal arms. The com­bi­na­tion of Imfinzi and chemother­a­py cut the risk of death by 27% (HR: 0.73; p=0.0047). Pa­tients on the Imfinzi arm lived a me­di­an 13 months longer, ver­sus 10.3 months in the chemother­a­py group.

The arm with treme­li­mum­ab failed to achieve the pri­ma­ry goal. The Imfinzi/treme­li­mum­ab com­bo, once tout­ed as the cor­ner­stone of As­traZeneca’s check­point de­vel­op­ment strat­e­gy, has al­ready seen a raft of fail­ures in the past — it did not im­prove over­all sur­vival in cer­tain pa­tients with head and neck can­cer, in ad­di­tion to the big flop in the keen­ly-watched MYS­TIC non-small cell lung can­cer (NSCLC) tri­al. Al­though the duo has, when com­bined with chemother­a­py, worked in de­lay­ing dis­ease pro­gres­sion in front­line cas­es of stage 4 NSCLC.

Roche’s Tecen­triq in com­bi­na­tion with chemother­a­py was ap­proved first-line treat­ment for ex­tend­ed stage SCLC last Sep­tem­ber, based on a 30% re­duc­tion in risk of death ob­served in the piv­otal IM­pow­er133 tri­al. Months ear­li­er in June, Mer­ck’s key­stone check­point in­hibitor Keytru­da had scored FDA ap­proval as a monother­a­py for the treat­ment of SCLC pa­tients who had pro­gressed on or af­ter plat­inum-based chemother­a­py and at least one pri­or line of ther­a­py.

On Mon­day, the FDA ap­proved the Imfinzi plus chemother­a­py com­bi­na­tion as a first-line treat­ment for ex­tend­ed-stage SCLC pa­tients, pit­ting against Tecen­triq it in the ex­act same pa­tient pop­u­la­tion.

Mean­while, Phar­ma­Mar’s lur­binecte­din re­ceived pri­or­i­ty re­view last month for the treat­ment of SCLC pa­tients who pro­gressed on plat­inum ther­a­py based on da­ta from a sin­gle-arm, mid-stage study show­ing an over­all re­sponse rate (ORR) of about 35%.

Lung can­cer is the lead­ing cause of can­cer death glob­al­ly, ac­cord­ing to the WHO. The two main types of lung can­cer are non-small cell and small cell, and NSCLC ac­counts for about 85% of all cas­es. About two-thirds of SCLC pa­tients are di­ag­nosed with ex­tend­ed stage-SCLC, in which the can­cer has spread wide­ly through the lung or to oth­er parts of the body.

Paul Hudson, Sanofi CEO (Getty Images)

Sanofi CEO Paul Hud­son has $23B burn­ing a hole in his pock­et. And here are some hints on how he plans to spend that

Sanofi has reaped $11.1 billion after selling off a big chunk of its Regeneron stock at $515 a share. And now everyone on the M&A side of the business is focused on how CEO Paul Hudson plans to spend it.

After getting stung in France for some awkward politicking — suggesting the US was in the front of the line for Sanofi’s vaccines given American financial support for their work, versus little help from European powers — Hudson now has the much more popular task of managing a major cash cache to pull off something in the order of a big bolt-on. Or two.

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Pablo Legorreta, founder and CEO of Royalty Pharma AG, speaks at the annual Milken Institute Global Conference in Beverly Hills, California (Patrick T. Fallon/Bloomberg via Getty Images)

Cap­i­tal­iz­ing Pablo: The world’s biggest drug roy­al­ty buy­er is go­ing pub­lic. And the low-key CEO di­vulges a few se­crets along the way

Pablo Legorreta is one of the most influential players in biopharma you likely never heard of.

Over the last 24 years, Legorreta’s Royalty Pharma group has become, by its own reckoning, the biggest buyer of drug royalties in the world. The CEO and founder has bought up a stake in a lengthy list of the world’s biggest drug franchises, spending $18 billion in the process — $2.2 billion last year alone. And he’s become one of the best-paid execs in the industry, reaping $28 million from the cash flow last year while reserving 20% of the cash flow, less expenses, for himself.

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The Avance Clinical leadership team: CEO Yvonne Lungershausen, Sandrien Louwaars - Director Business Development Operations, Gabriel Kremmidiotis - Chief Scientific Officer, Ben Edwards - Chief Strategy Officer

How Aus­tralia De­liv­ers Rapid Start-up and 43.5% Re­bate for Ear­ly Phase On­col­o­gy Tri­als

About Avance Clinical

Avance Clinical is an Australian owned Contract Research Organisation that has been providing high-quality clinical research services to the local and international drug development industry for 20 years. They specialise in working with biotech companies to execute Phase 1 and Phase 2 clinical trials to deliver high-quality outcomes fit for global regulatory standards.

As oncology sponsors look internationally to speed-up trials after unprecedented COVID-19 suspensions and delays, Australia, which has led the world in minimizing the pandemic’s impact, stands out as an attractive destination for early phase trials. This in combination with the streamlined regulatory system and the financial benefits including a very favourable exchange rate and the R & D cash rebate makes Australia the perfect location for accelerating biotech clinical programs.

As­traZeneca trum­pets the good da­ta they found for Tagris­so in an ad­ju­vant set­ting for NSCLC — but many of the ex­perts aren’t cheer­ing along

AstraZeneca is rolling out the big guns this evening to provide a salute to their ADAURA data on Tagrisso at ASCO.

Cancer R&D chief José Baselga calls the disease-free survival data for their drug in an adjuvant setting of early stage, epidermal growth factor receptor-mutated NSCLC patients following surgery “momentous.” Roy Herbst, the principal investigator out of Yale, calls it “transformative.”

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Iron­wood kicks de­layed-re­lease Linzess for­mu­la­tion to the curb af­ter tri­al fail­ure

The delayed-release formulation of Ironwood and Allergan’s bowel drug Linzess will not see the light of day.

The experimental drug, MD-7246, failed to help patients with abdominal pain associated with irritable bowel syndrome with diarrhea (IBS-D) in a mid-stage study, prompting the partners to abandon the therapy.

First approved in 2012, Linzess (known chemically as linaclotide) enhances the activity of the intestinal enzyme guanylate cyclase-C to increase the secretion of intestinal fluid and then transit through the intestinal tract, as well as reduce visceral pain, to relieve pain and constipation associated with IBS.

Dan O'Day, Gilead CEO (Andrew Harnik, AP Images)

UP­DAT­ED: Gilead leas­es part­ner rights to TIG­IT, PD-1 in a $2B deal with Ar­cus. Now comes the hard part

Gilead CEO Dan O’Day has brokered his way to a PD-1 and lined up a front row seat in the TIGIT arena, inking a deal worth close to $2 billion to align the big biotech closely with Terry Rosen’s Arcus. And $375 million of that comes upfront, with cash for the buy-in plus equity, along with $400 million for R&D and $1.22 billion in reserve to cover opt-in payments and milestones..

Hotly rumored for weeks, the 2 players have formalized a 10-year alliance that starts with rights to the PD-1, zimberelimab. O’Day also has first dibs on TIGIT and 2 other leading programs, agreeing to an opt-in fee ranging from $200 million to $275 million on each. There’s $500 million in potential TIGIT milestones on US regulatory events — likely capped by an approval — if Gilead partners on it and the stars align on the data. And there’s another $150 million opt-in payments for the rest of the Arcus pipeline.

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No­var­tis jumps in­to Covid-19 vac­cine hunt, as Big Phar­ma and big biotech com­mit to bil­lions of dos­es

After spending most of the pandemic on the sidelines, Novartis is offering its aid in the race to develop a Covid-19 vaccine.

AveXis, the Swiss pharma’s gene therapy subsidiary, has agreed to manufacture the vaccine being developed by Massachusetts Eye and Ear and Massachusetts General Hospital. The biotech will begin manufacturing this month, while the vaccine undergoes further preclinical testing. They’ve agreed to provide the vaccine for free for clinical trials beginning in the second half of 2020, but have not disclosed financials for after.

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Roger Perlmutter, Merck R&D chief (YouTube)

UP­DAT­ED: Backed by BAR­DA, Mer­ck jumps in­to Covid-19: buy­ing out a vac­cine, part­ner­ing on an­oth­er and adding an­tivi­ral to the mix

Merck execs are making a triple play in a sudden leap into the R&D campaign against Covid-19. And they have more BARDA cash backing them up on the move.

Tuesday morning the pharma giant simultaneously announced plans to buy an Austrian biotech that has been working on a preclinical vaccine candidate, added a collaboration on another vaccine with the nonprofit IAVI and inked a deal with Ridgeback Biotherapeutics on an early-stage antiviral.

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Bris­tol My­ers Squibb fi­nal­ly gets in the front­line NSCLC game dom­i­nat­ed by Mer­ck, adding a sec­ond Op­di­vo/Yer­voy-based op­tion

Bristol Myers Squibb may be trailing Merck and Roche in the checkpoint race to treat frontline cases of non-small cell lung cancer, but as it does, it makes sure to bring its best feet forward.

Just days after scoring a landmark NSCLC approval for Opdivo and Yervoy alone for PD-L1 positive patients, the company said the FDA has also OK’d using the two agents with a limited course of chemo regardless of the biomarker status.

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