A ground­break­ing can­cer drug nabs fast OK, giv­ing Eli Lil­ly boast­ing rights as a ri­val speeds close be­hind

Eli Lil­ly $LLY has scored the fast FDA ap­proval it was gun­ning for when the phar­ma gi­ant plunked down $8 bil­lion to ac­quire Loxo On­col­o­gy back at the be­gin­ning of 2019. Reg­u­la­tors stamped their OK on selper­ca­tinib, which can now be mar­ket­ed as Retev­mo to pa­tients suf­fer­ing from 3 dif­fer­ent types of can­cers all dri­ven by the same gene al­ter­ation.

The ap­proval marks an­oth­er win for ad­vo­cates of rapid de­vel­op­ment, with the Loxo team jump­ing from their first treat­ment to an ap­proval on Phase I/II da­ta in 3 short years. And it comes just 3 months af­ter the FDA’s can­cer group hand­ed Lil­ly a pri­or­i­ty re­view, in­di­cat­ing that the agency still finds it easy to re­ward ad­vances in the field with speedy an­swers — de­spite the pan­dem­ic.

For Lil­ly, the drug OK al­so marks a rare first place fin­ish, but Blue­print Med­i­cines $BPMC is ex­pect­ed to quick­ly counter with new da­ta at AS­CO on a ri­val that is one step be­hind the phar­ma gi­ant.

The phar­ma play­er got the mar­ket­ing ball rolling with a $20,600 per month price on the ther­a­py.

But they don’t have a lock on best-in-class sta­tus. As Steve Scala at Cowen not­ed Mon­day morn­ing:

The la­bel con­tains pos­i­tives (line ag­nos­tic, in­creased ef­fi­ca­cy in thy­roid can­cer) and neg­a­tives (safe­ty warn­ings in­clud­ing liv­er mon­i­tor­ing, in­cre­men­tal downtick in lung ef­fi­ca­cy). All told, the la­bel is in­cre­men­tal­ly worse than hoped. Long-term dura­bil­i­ty da­ta is now more im­por­tant.

The FDA ac­tion cov­ers RET fu­sion-pos­i­tive non-small cell lung can­cer and thy­roid can­cer, along with RET-mu­tant medullary thy­roid can­cer. In the ab­sence of an ap­proved test to spot the al­ter­ation, Lil­ly sug­gests us­ing bio­mark­ers to iden­ti­fy pa­tients.

That is no easy propo­si­tion, as on­ly 2% of NSCLC pa­tients will be in­clud­ed. But it’s a large enough group to push the field to­ward more test­ing. It al­so helps that No­var­tis just got an OK for cap­ma­tinib a few days ago, adding an­oth­er drug used on the ba­sis of a gene al­ter­ation that dri­ves cell pro­lif­er­a­tion. As more of these drugs are ap­proved, test­ing and se­quenc­ing will grow more com­mon, al­low­ing for bet­ter out­comes for all.

Blue­print is al­so like­ly to help that process if their next round of da­ta for pralse­tinib — now un­der FDA re­view — in RET fu­sion pos­i­tive NSCLC high­lights pos­i­tive re­sults. An ap­pli­ca­tion for RET-mu­tant medullary thy­roid can­cer is ex­pect­ed any week now.

An­drew Berens at SVB Leerink has been track­ing the com­pe­ti­tion from Blue­print’s per­spec­tive, and re­cent­ly not­ed how the matchup will be scored based on AS­CO da­ta:

We ex­pect in­vestor fo­cus (on pralse­tinib) to be on DOR rel­a­tive to selper­ca­tinib, which has shown me­di­an DOR of 20.3 months. How­ev­er, some in­vestors are fo­cused on the me­di­an PFS as the rel­a­tive bench­mark of ef­fi­ca­cy, with LOXO’s selper­ca­tinib show­ing 18.4 months at WCLC 2019.

The FDA ac­tion on Fri­day serves as fur­ther val­i­da­tion for Lil­ly’s de­ci­sion to turn over the on­col­o­gy group to the Loxo team, led by Josh Bilenker. Lil­ly’s can­cer team has had a lack­lus­ter per­for­mance record over the years, which Bilenker’s group was brought on to rem­e­dy. Since then, they’ve been clean­ing up the pipeline and prep­ping new deals as Lil­ly looks to join big play­ers like GSK and Sanofi, which are look­ing to turn things around with some fast-ac­tion can­cer plays.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA have vowed not to let politics get in the way of science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped health agencies under his purview — including the FDA — of their rulemaking ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Eli Lilly CSO Dan Skovronsky (file photo)

#ES­MO20: Eli Lil­ly shows off the da­ta for its Verzenio suc­cess. Was it worth $18 bil­lion?

The press release alone, devoid of any number except for the size of the trial, added nearly $20 billion to Eli Lilly’s market cap back in June. Now investors and oncologists will get to see if the data live up to the hype.

On Sunday at ESMO, Eli Lilly announced the full results for its Phase III MonarchE trial of Verzenio, showing that across over 5,000 women who had had HR+, HER2- breast cancer, the drug reduced the odds of recurrence by 25%. That meant 7.8% of the patients on the drug arm saw their cancers return within 2 years, compared with 11.3% on the placebo arm.

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Dan Skovronsky, Eli Lilly CSO

UP­DAT­ED: An­a­lysts are quick to pan Eli Lil­ly's puz­zling first cut of pos­i­tive clin­i­cal da­ta for its Covid-19 an­ti­body

Eli Lilly spotlighted a success for one of 3 doses of their closely-watched Covid-19 antibody drug Wednesday morning. But analysts quickly highlighted some obvious anomalies that could come back to haunt the pharma giant as it looks for an emergency use authorization to launch marketing efforts.

The pharma giant reported that LY-CoV555, developed in collaboration with AbCellera, significantly reduced the rate of hospitalization among patients who were treated with the antibody. The drug arm of the study had a 1.7% hospitalization rate, compared to 6% in the control group, marking a 72% drop in risk.

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Greg Friberg (File photo)

#ES­MO20: Am­gen team nails down sol­id ear­ly ev­i­dence of AMG 510’s po­ten­tial for NSCLC, un­lock­ing the door to a wave of KRAS pro­grams

The first time I sat down with Amgen’s Greg Friberg to talk about the pharma giant’s KRAS G12C program for sotorasib (AMG 510) at ASCO a little more than a year ago, there was high excitement about the first glimpse of efficacy from their Phase I study, with 5 of 10 evaluable non-small cell lung cancer patients demonstrating a response to the drug.

After decades of failure targeting KRAS, sotorasib offered the first positive look at a new approach that promised to open a door to a whole new approach by targeting a particular mutation to a big target that had remained “undruggable” for decades.

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#ES­MO20: Out to beat Tagris­so, J&J touts 100% ORR for EGFR bis­pe­cif­ic/TKI com­bo — fu­el­ing a quick leap to PhI­II

J&J’s one-two punch on EGFR-mutant non-small cell lung cancer has turned up some promising — although decidedly early — results, fueling the idea that there’s yet room to one up on third-generation tyrosine kinase inhibitors.

Twenty out of 20 advanced NSCLC patients had a response after taking a combination of an in-house TKI dubbed lazertinib and amivantamab, a bispecific antibody targeting both EGFR and cMET engineered on partner Genmab’s platform, J&J reported at ESMO. All were treatment-naïve, and none has seen their cancer progress at a median follow-up of seven months.

#ES­MO20: It’s not just Keytru­da any­more — Mer­ck spot­lights 3 top ear­ly-stage can­cer drugs

Any $12 billion megablockbuster in the portfolio tends to overshadow everything else in the pipeline. Which is something Merck can tell you a little bit about.

Keytruda not only dominates the PD-(L)1 field, it looms over everything Merck does, to the point some analysts wonder if Merck is a one-trick pony.

There’s no shortage of Keytruda data on display at ESMO this weekend, but now the focus is shifting to the future role of new drugs and combos in maintaining that lead position for years to come. And the pharma giant has a special focus for 3 early-stage efforts where Roger Perlmutter’s oncology team is placing some big bets.

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Exelixis CEO Michael Morrissey (file photo)

#ES­MO20: Look out Mer­ck. Bris­tol My­ers and Ex­elix­is stake out their com­bo’s claim to best-in-class sta­tus for front­line kid­ney can­cer

Now that the PD-(L)1 checkpoints are deeply entrenched in the oncology market, it’s time to welcome a wave of combination therapies — beyond chemo — looking to extend their benefit to larger numbers of patients. Bristol Myers Squibb ($BMY} and Exelixis {EXEL} are close to the front of that line.

Today at ESMO the collaborators pulled the curtain back on some stellar data for their combination of Opdivo (the PD-1) and Cabometyx (the TKI), marking a significant advance for the blockbuster Bristol Myers franchise while offering a big leg up for the team at Exelixis.

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#ES­MO20: Trodelvy da­ta show that Gilead­'s $21B buy­out may have been worth the big pre­mi­um

Gilead CEO Dan O’Day has been on a shopping spree. And while some analysts gawked at the biotech’s recent $21 billion Immunomedics buyout, new data released at virtual ESMO 2020 suggest the acquisition may have been worth the hefty price.

The deal, announced last weekend, will give California-based Gilead $GILD Trodelvy, which was recently approved for metastatic triple-negative breast cancer (mTNBC).

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#ES­MO20: As­traZeneca bur­nish­es Tagris­so's ad­ju­vant NSCLC pro­file with 'un­prece­dent­ed' re­duc­tion in brain mets. Can they win over skep­tics?

When AstraZeneca trumpeted “momentous” and “transformative” results for Tagrisso earlier this year at ASCO, some practitioners threw cold water on the ADAURA fervor. Sure, the disease-free survival data look good, but overall survival is the endpoint that matters when it comes to choosing adjuvant therapy for non-small cell lung cancer patients, the experts said.

The OS data still aren’t here, but AstraZeneca is back at ESMO to bolster their case with a look at brain metastasis data.