Roche racks up an­oth­er check­point win as Tecen­triq scores in lat­est PhI­II lung can­cer study

Com­ing fast on the heels of Bris­tol-My­ers Squibb’s sting­ing set­back with its star can­cer ther­a­py Op­di­vo, Roche says that its PD-L1 check­point drug Tecen­triq (ate­zolizum­ab) hit its key goals in a Phase III study for non-small cell lung can­cer, ex­tend­ing the lives of pa­tients in the tri­al.

San­dra Horn­ing, Roche CMO

The phar­ma gi­ant’s big Genen­tech unit re­port­ed that Tecen­triq met its co-pri­ma­ry end­points on im­prov­ing sur­vival rates for the over­all pop­u­la­tion of lung can­cer pa­tients as well as a spe­cif­ic sub­group se­lect­ed by PD-L1 ex­pres­sion, a cru­cial bio­mark­er for this treat­ment. In­ves­ti­ga­tors gath­ered the da­ta among 1,225 pa­tients whose lung can­cer had spread on or af­ter chemo.

The phar­ma gi­ant was stick­ing with top-line da­ta on­line in this first analy­sis, hold­ing back the spe­cif­ic re­sults for an up­com­ing sci­en­tif­ic con­fer­ence — stan­dard prac­tice in R&D, at least for pos­i­tive stud­ies.  And Roche says it plans to hus­tle the new da­ta to the FDA as it works in­tent­ly on grow­ing the mar­ket.

The suc­cess lands just weeks af­ter Bris­tol-My­ers man­aged to stun just about every­one in the on­col­o­gy field with the news that its Phase III for its PD-1 drug Op­di­vo in first-line lung can­cer pa­tients had failed, in­stant­ly giv­ing Mer­ck a big edge in a huge mar­ket. Op­di­vo’s fail­ure star­tled a big crowd of in­vestors who had be­come used to con­sid­er­ing Op­di­vo as the dom­i­nant play­er, dis­rupt­ing a field that is de­liv­er­ing megablock­buster re­turns.

Roche has been play­ing catch-up with Bris­tol-My­ers — the dom­i­nant play­er — and Mer­ck. But it has at­tract­ed con­sid­er­able at­ten­tion for its com­ple­men­tary PD-L1 ap­proach, which is carv­ing out its own place in the mar­ket af­ter gain­ing its first ap­proval for blad­der can­cer back in May.

Bris­tol-My­ers’ set­back in the check­point field — where drugs dis­man­tle a mech­a­nism that hides can­cer cells from an im­mune sys­tem at­tack — spurred some sig­nif­i­cant crit­i­cism that the com­pa­ny had tried to tack­le a pa­tient pop­u­la­tion too big to de­liv­er pos­i­tive re­sults, forc­ing in­ves­ti­ga­tors to re­think how they de­sign and ex­e­cute Phase III stud­ies for a check­point pro­gram. Re­searchers on the Bris­tol-My­ers study had re­cruit­ed a broad pop­u­la­tion of 541 pre­vi­ous­ly un­treat­ed first line pa­tients whose tu­mors ex­pressed PD-L1 at a low lev­el of ≥ 5%.

Genen­tech, mean­while, has eight late-stage stud­ies on­go­ing for var­i­ous stages of lung can­cer, high­light­ing its sig­nif­i­cance in a boom­ing field. And with break­through sta­tus at the FDA, it ex­pects to hus­tle up a whole slate of ap­pli­ca­tions to ex­pand its use.

Sea­mus Fer­nan­dez at Leerink sees tougher head­winds ahead for Op­di­vo now:

At a min­i­mum, we have to as­sume that this re­sult will in­crease the view that PD-1 & PD-L1 an­ti­bod­ies have very sim­i­lar ef­fi­ca­cy pro­files, re­sult­ing in in­creased com­pe­ti­tion in 2L lung can­cer – Op­di­vo’s cur­rent strong­hold. In our view, this places even greater im­por­tance on a pos­i­tive out­come in the Check­Mate-227 (CM-227) tri­al of Op­di­vo + Yer­voy (ip­il­i­mum­ab; CT­LA-4 in­hibitor) in 1L NSCLC. While full re­sults of the OAK tri­al will de­ter­mine if physi­cians will dis­tin­guish Tecen­triq com­mer­cial­ly, we be­lieve the top line re­sults sug­gest less ef­fi­ca­cy dif­fer­en­ti­a­tion be­tween Tecen­triq, Op­di­vo, and Mer­ck’s (MP) Keytru­da (pem­brolizum­ab; PD-1 in­hibitor), and near-term, MRK is like­ly to main­tain the most unique op­por­tu­ni­ty in 1st line NSCLC.

San­dra Horn­ing, Roche’s chief med­ical of­fi­cer and head of Glob­al Prod­uct De­vel­op­ment, had this to say:

“These re­sults add to the grow­ing body of ev­i­dence that sup­ports the role of Tecen­triq as a po­ten­tial new treat­ment for spe­cif­ic types of ad­vanced NSCLC. This is very en­cour­ag­ing news for peo­ple liv­ing with this dis­ease be­cause lung can­cer is the lead­ing cause of can­cer deaths around the world. We hope to bring this treat­ment op­tion to pa­tients as soon as pos­si­ble.”

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,700+ biopharma pros reading Endpoints daily — and it's free.

Credit: Shutterstock

How Chi­na turned the ta­bles on bio­phar­ma's glob­al deal­mak­ing

Fenlai Tan still gets chills thinking about the darkest day of his life.

Three out of eight lung cancer patients who received a tyrosine kinase inhibitor developed by his company, Betta Pharma, died in the span of a month. Tan, the chief medical officer, was summoned to Peking Union Medical College Hospital, where the head of the clinical trial department told him that the trial investigators would be conducting an autopsy to see if the patients had died of the disease — they were all very sick by the time they enrolled — or of interstitial lung disease, a deadly side effect tied to the TKI class that’s been reported in Japan.

No­var­tis dumps AveX­is pro­gram for Rett syn­drome af­ter fail­ing re­peat round of pre­clin­i­cal test­ing

Say goodbye to AVXS-201.

The Rett syndrome gene therapy drug made by AveXis — the biotech that was bought, kept separate, then renamed and finally absorbed by Novartis into its R&D division — has been dropped by the biopharma.

In Novartis’ third quarter financial report, the pharma had found that preclinical data did not support development of the gene therapy into IND-enabling trials and beyond. The announcement comes a year after Novartis told the Rett Society how excited it was by the drug — and its potential benefits and uses.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,700+ biopharma pros reading Endpoints daily — and it's free.

FDA is much worse than its reg­u­la­to­ry peers at proac­tive­ly dis­clos­ing da­ta, re­searchers find

The European Medicines Agency and Health Canada continue to outpace the FDA when it comes to proactively releasing data on drugs and biologics the agency has reviewed, leading to further questions of why the American agency can’t be more transparent.

In a study published recently in the Journal of Law, Medicine, & Ethics, Yale and other academic lawyers and researchers found that between 2016 and April 2021, the EMA proactively released data for 123 unique medical products, while Health Canada proactively released data for 73 unique medical products between 2019 and April 2021. What’s more, the EMA and Health Canada didn’t proactively release the same data on the same drugs. In stark contrast, the FDA in 2018 only proactively disclosed data supporting one drug that was approved that year.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,700+ biopharma pros reading Endpoints daily — and it's free.

Ugur Sahin, AP Images

As pres­sure to share tech­nol­o­gy mounts, BioN­Tech se­lects Rwan­da for lat­est vac­cine site

BioNTech’s first mRNA-based vaccine site in Africa will call Rwanda home, and construction is set to start in mid-2022, the company announced Tuesday at a public health forum.

The German company signed a memorandum of understanding, after a meeting between Rwanda’s Minister of Health, Daniel Ngamije, Senegal’s Minister of Foreign Affairs Aïssata Tall Sall, and senior BioNTech officials. Construction plans have been finalized, and assets have been ordered. The agreement will help bring end-to-end manufacturing to Africa, and as many as several hundred million doses of vaccines per year, though initial production will be more modest.

ARCH-backed SciNeu­ro kicks off search for CNS au­toan­ti­bod­ies with new deal; Mer­ck + Gilead an­nounce PhII tri­al for HIV com­bo

From the very beginning at SciNeuro, CEO Min Li has envisioned a mix of licensing deals and scientific efforts to replicate the breakout success of China’s oncology companies in neuroscience.

The GlaxoSmithKline vet has now inked a deal that somewhat straddles the line between the two strategies.

Teaming up with Mabylon out of Zurich, SciNeuro is now looking to test the hypothesis that the human immune system can play a role in fighting neurodegenerative diseases by discovering and developing human autoantibodies against neurological “targets of mutual interests.” The new partners offered TAR DNA binding protein-43 (TDP-43) and apolipoprotein E (APOE), which are linked to ALS and Alzheimer’s, as examples.

UP­DAT­ED: Eli Lil­ly toss­es a mar­quee pain drug and hits the gas on Alzheimer’s — as Bio­gen’s suf­fer­ing opens mar­ket to ri­vals

The furious chorus of critics that brought sales of Biogen’s ultra controversial Alzheimer’s drug aducanumab (sold as Aduhelm) to a near halt is opening up some big opportunities for a major league rival that has long sought the lead role in this largely untapped megamarket.

In its Q3 update today, Eli Lilly — noted for its dogged persistence in attempting for years to get solanezumab across the FDA finish line — said that it has begun a rolling submission of its rival Alzheimer’s drug donanemab in search of an accelerated approval. Anne White, senior VP of Lilly’s neuroscience unit, acknowledged during the investor call the challenges Biogen has faced with uptake and noted Lilly may face similar hurdles.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,700+ biopharma pros reading Endpoints daily — and it's free.

Vas Narasimhan, Novartis CEO (Simon Dawson/Bloomberg via Getty Images)

With San­doz con­tin­u­ing to drag on No­var­tis, Vas Narasimhan says he may fi­nal­ly be ready for a sale or spin­off

After years of rehab work aimed at getting Sandoz in fighting trim to compete in a market overshadowed by declining prices, CEO Vas Narasimhan took a big step toward possibly selling or spinning off the giant generic drug player.

The pharma giant flagged plans to launch a strategic review of the business in its Q3 update, noting that “options range from retaining the business to separation.”

Analysts have been poking and prodding Novartis execs for years now as Narasimhan attempted to remodel a business that has been a drag on its performance during most of his reign in the CEO suite. The former R&D chief has made it well known that he’s devoted to the innovative meds side of the business, where they see the greatest potential for growth.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,700+ biopharma pros reading Endpoints daily — and it's free.