UP­DAT­ED: J&J beats Tagris­so and Take­da to the punch in key NSCLC sub­set, pick­ing up new FDA ap­proval

Look­ing to out­flank As­traZeneca’s best-sell­ing drug in a non-small cell lung can­cer niche, J&J scored an im­por­tant ap­proval Fri­day af­ter­noon.

Reg­u­la­tors gave the thumbs-up to Janssen’s ami­van­tam­ab for the treat­ment of metasta­t­ic NSCLC with EGFR ex­on 20 in­ser­tion mu­ta­tions, the FDA an­nounced Fri­day. It’s the first drug ap­proved to treat such pa­tients, with J&J plant­i­ng a stake in a part of the EGFR mu­ta­tion are­na where its com­peti­tors have strug­gled to gain a foothold.

The drug, whose ap­proval comes af­ter J&J jumped straight from a Phase I study to a BLA pri­or­i­ty re­view, will be brand­ed as Ry­bre­vant. In an emailed state­ment to End­points News, J&J de­clined to com­ment on spe­cif­ic pric­ing for the drug, say­ing on­ly that it would “re­flect its in­cre­men­tal val­ue” in NSCLC out­comes for this pop­u­la­tion and be “com­pa­ra­ble to oth­er in­fused on­col­o­gy med­i­cines.”

While lung can­cer is the most com­mon form of can­cer and is the lead­ing cause of world­wide can­cer deaths, pa­tients with EGFR ex­on 20 in­ser­tion mu­ta­tions had been ex­clud­ed from tak­ing pre­vi­ous­ly ap­proved drugs — on­ly about 2% to 3% of NSCLC pa­tients have these mu­ta­tions, the FDA said. That list in­cludes As­traZeneca’s block­buster Tagris­so, which raked in more than $4 bil­lion last year.

Tagris­so is on­ly OK’ed for ex­on 19 dele­tions or ex­on 21 L858R mu­ta­tions, or pa­tients with EGFR mu­ta­tions who had un­der­gone tu­mor re­sec­tion and op­tion­al, stan­dard post­op­er­a­tive ad­ju­vant chemother­a­py.

One of the pri­ma­ry rea­sons past med­i­cines haven’t worked in this new class is the drugs don’t bind all that well to the tar­get, J&J in­ves­ti­ga­tor Joshua Sabari told End­points ahead of WCLC in Jan­u­ary. But Ry­bre­vant is an EGFR/MET bis­pe­cif­ic that binds out­side of the cell, which J&J says bet­ter in­hibits tu­mor growth among the ex­on 20 in­ser­tion mu­ta­tion pop­u­la­tion.

Fri­day’s ap­proval was based on those WCLC Phase I da­ta, look­ing at 81 pa­tients whose NSCLC had pro­gressed on or af­ter plat­inum chemo. With­in the study, 32 in­di­vid­u­als saw at least a par­tial re­sponse, good for an ORR of 39.5%. The re­spons­es were al­so shown to last with the drug prompt­ing a me­di­an du­ra­tion of 11.1 months, and 20 of the 32 pa­tients demon­strat­ed a re­sponse of at least six months.

J&J like­ly won’t be sat­is­fied with just this in­di­ca­tion giv­en the com­pe­ti­tion from Tagris­so and an­oth­er pro­gram from Take­da called mobo­cer­tinib.

Re­searchers are con­tin­u­ing to study how Ry­bre­vant can af­fect ad­vanced NSCLC pa­tients when used in com­bi­na­tion with an in-house TKI called laz­er­tinib, pit­ting this com­bo head-to-head with Tagris­so in a Phase III tri­al in pre­vi­ous­ly un­treat­ed pa­tients. There’s al­so an­oth­er tri­al for the Ry­bre­vant/laz­er­tinib duo in­volv­ing pa­tients who have tak­en both Tagris­so and chemother­a­py but still pro­gressed.

The Take­da can­di­date pre­sent­ed da­ta back in Jan­u­ary show­ing a sim­i­lar over­all re­sponse rate of 35%, but high rates of se­vere GI side ef­fects could tem­per ex­pec­ta­tions. Ear­li­er this week at AS­CO, how­ev­er, mobo­cer­tinib post­ed a me­di­an OS of 24 months at a 14-month fol­low-up.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Roche's Tecen­triq cross­es the fin­ish line first in ad­ju­vant lung can­cer, po­ten­tial­ly kick­ing off gold rush

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'


Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

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FDA ad­comm votes unan­i­mous­ly in sup­port of a J&J Covid-19 boost­er two months af­ter one-dose shot

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Friday voted 19-0 in favor of authorizing a second shot of J&J’s Covid-19 vaccine to follow at least two months after the initial dose.

Regulators don’t have to follow VRBPAC’s recommendation, but they almost always do. Considering that the CDC’s advisory committee has already been set to review the expanded EUA, VRBPAC’s recommendation is likely to be adopted.

In­cyte yanks EU ap­pli­ca­tion for PD-1 drug, cit­ing in­abil­i­ty to an­swer reg­u­la­tors' 'ma­jor con­cern­s'

Hoping to wedge its way into a crowded PD-(L)1 field, Incyte faced a huge setback when the FDA sent back its application for an initial indication earlier this year. Now, the drugmaker is giving up hope in Europe as well.

Incyte has withdrawn its EU application for PD-1 drug Zynyz, or retifanlimab, after saying it couldn’t adequately address the CHMP’s questions over survival data underpinning its market hopes in squamous cell carcinoma of the anal cavity, the EMA revealed.

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FDA's vac­cine ad­comm unan­i­mous­ly sup­ports Mod­er­na's boost­er in same pop­u­la­tions as Pfiz­er's boost­er

The FDA’s vaccine advisory committee on Thursday voted 19-0 in support of expanding Moderna’s Covid-19 vaccine EUA for booster doses for certain high-risk individuals. FDA is expected to authorize the Moderna booster shortly.

Similarly to the Pfizer booster shot, Moderna’s will likely be authorized for those older than 65, adults at high risk of severe Covid-19, and adults whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of Covid-19. But unlike the Pfizer adcomm, where FDA had to scramble to get the committee to vote in favor of a booster, this committee was unanimous with the Moderna shot.