Af­ter get­ting skunked by ri­vals, Pfiz­er touts ‘break­through’ can­cer drug lor­la­tinib, heads to the FDA

Mace Rothen­berg, Pfiz­er

Pfiz­er’s Xalko­ri has be­come a Phase III punch­ing bag of sorts for top ri­vals in the can­cer field. In June No­var­tis’ Zyka­dia picked up an FDA ap­proval to chal­lenge Xalko­ri in front­line ALK-pos­i­tive lung can­cer. And Roche’s Ale­cen­sa has been whup­ping up on Xalko­ri as well, prov­ing bet­ter at cut­ting the risk of dis­ease pro­gres­sion.

So it’s no won­der that Pfiz­er is tak­ing its pos­i­tive Phase II da­ta — post­ed to­day — for its next-gen suc­ces­sor lor­la­tinib straight to reg­u­la­tors.

Now in Phase III, Pfiz­er won a break­through ther­a­py des­ig­na­tion for lor­la­tinib from the FDA ear­li­er this year, promis­ing a speedy re­view at an agency that has be­come a mas­ter at mak­ing ac­cel­er­at­ed can­cer drug de­ci­sions.

De­signed for ALK-pos­i­tive and ROS1-pos­i­tive ad­vanced non-small cell lung can­cer, re­searchers high­light­ed a slate of the mid-stage da­ta on the drug.

The key da­ta points:

  • In ALK-pos­i­tive treat­ment-naïve pa­tients, the over­all re­sponse rate was 90%. The in­tracra­nial ORR (IC-ORR) was 75%.
  • For ALK-pos­i­tive pa­tients pre­vi­ous­ly treat­ed with Xalko­ri (crizo­tinib) with or with­out chemother­a­py: ORR was 69%, the IC-ORR was 68%.
  • In ALK-pos­i­tive pa­tients pre­vi­ous­ly treat­ed with a non-crizo­tinib ALK in­hibitor with or with­out chemother­a­py: ORR was 33%.
  • ALK-pos­i­tive pre­vi­ous­ly treat­ed with two or three pri­or ALK in­hibitors with or with­out chemother­a­py: ORR was 39%.
  • ROS1-pos­i­tive re­gard­less of pri­or treat­ment: ORR was 36%.

Now look for Pfiz­er to press hard to punch back at No­var­tis and Roche in de­fense of its can­cer drug fran­chise. Pfiz­er’s made on­col­o­gy a chief fo­cus in the pipeline, scor­ing some of its biggest gains in the field as it added new drugs through the Medi­va­tion buy­out. And as bil­lions gets poured in­to new re­search, pa­tients have ben­e­fit­ed from the quick adop­tion of some game-chang­ing ther­a­pies.

“Lor­la­tinib is an ex­tra­or­di­nary ex­am­ple of what can be achieved through trans­la­tion­al re­search and pre­ci­sion med­i­cine de­vel­op­ment. Re­call that Xalko­ri (crizo­tinib) was the first drug ap­proved for pa­tients with ALK-pos­i­tive and ROS1-pos­i­tive NSCLC. By un­der­stand­ing the mu­ta­tions that oc­curred in pa­tients that ren­dered their tu­mors re­sis­tant to Xalko­ri and oth­er ALK in­hibitors, med­i­c­i­nal chemists work­ing at Pfiz­er were able to de­sign a mol­e­cule with the po­ten­tial to over­come that re­sis­tance and in­hib­it ALK de­spite these mu­ta­tions. We are very en­cour­aged by the re­sults of this Phase 2 tri­al that pro­vide the first clin­i­cal ev­i­dence of the ac­tiv­i­ty of lor­la­tinib in this set­ting,” said Mace Rothen­berg, chief de­vel­op­ment of­fi­cer, on­col­o­gy, Pfiz­er glob­al prod­uct de­vel­op­ment.

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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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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The Advance 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.

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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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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Bryan Roberts, Venrock

Ven­rock sur­vey shows grow­ing recog­ni­tion of coro­n­avirus toll, wan­ing con­fi­dence in ar­rival of vac­cines and treat­ments

When Venrock partner Bryan Roberts went to check the results from their annual survey of healthcare leaders, what he found was an imprint of the pandemic’s slow arrival in America.

The venture firm had sent their form out to hundreds of insurance and health tech executives, investors, officials and academics on February 24 and gave them two weeks to fill it out. No Americans had died at that point but the coronavirus had become enough of a global crisis that they included two questions about the virus, including “Total U.S. deaths in 2020 from the novel coronavirus will be:”.

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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David Hoey (Vaxxas)

In for the long vac­cine game, Mer­ck buys in­to patch de­liv­ery tech with pan­dem­ic po­ten­tial

When Merck dived into the R&D fray for a Covid-19 vaccine earlier this week, execs made it clear that they’re not necessarily looking to be first — with CEO Ken Frazier throwing cold water on the hotly-discussed 12- to 18-month timelines. But when it does emerge from behind, the pharma giant clearly expects to play a significant part.

Part of that will depend on next-generation delivery technology that reshapes the world’s imagination of a vaccine.

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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