Check­point com­bos for can­cer are all the rage as tri­al spon­sors line up hun­dreds of new stud­ies — re­port

Num­ber of An­ti-PD-1/PD-L1 MAb com­bi­na­tion stud­ies 2015 vs. 2017
Full Re­port: Eval­u­ate Ltd. May 2017


Over the last few months it hasn’t been un­usu­al to see new com­bi­na­tion stud­ies be­ing an­nounced on a dai­ly ba­sis, match­ing one of the 5 ap­proved PD-(L)1 check­point drugs with an­oth­er can­cer ther­a­py. Some morn­ings they come in pairs.

It’s not hard to see why. The check­points typ­i­cal­ly work as a monother­a­py — though there have been some nasty set­backs over the past 6 months. And some of the big play­ers are hap­py to con­tribute their drug to stud­ies spon­sored by oth­ers look­ing to ad­vance a pi­lot Phase I/II ex­plorato­ry study. There are al­so re­cent ex­am­ples of some big tie-ups be­tween Mer­ck (Keytru­da) and Bris­tol-My­ers Squibb (Op­di­vo) check­points with In­cyte in Phase III.

In­cyte has its own PD-1 in the clin­ic as it lines up these ag­nos­tic late-stage tri­als to po­si­tion its lead­ing IDO1 drug.

Now EP Van­tage has tal­lied the whole score on these com­bo tri­als, not co­in­ci­den­tal­ly just ahead of AS­CO, and found a stun­ning 765 com­bi­na­tion stud­ies list­ed on clin­i­cal­tri­als.gov. Keytru­da leads the pack, with 268 — up from 70 just 18 months ago. For Bris­tol-My­ers it’s 242, more than three times the num­ber EP Van­tage’s ed­i­to­r­i­al team found in 2015.

Any­one even mod­er­ate­ly in­ter­est­ed in this field will want to check it out di­rect­ly. There’s a lot of de­tail on what’s now in the clin­ic.

Don’t ex­pect the ris­ing trend lines to start to plateau any­time soon, ei­ther, as Pfiz­er/Mer­ck KGaA (Baven­cio) and As­traZeneca (Imfinzi) start to gain trac­tion on the com­bo front. Roche al­ready emerged as the num­ber three play­er in the field with Tecen­triq, though its re­cent Phase III fail­ure for its check­point may chill oth­er would-be part­ners.

Mean­while, new check­point play­ers like BeiGene and Lil­ly are mov­ing along, the re­port notes, while No­var­tis has been ad­vanc­ing its own in-house check­point pro­grams. The sec­ond wave of PD-(L)1 ther­a­pies will be large.

One of the key next steps in this field is in As­traZeneca’s hands. It has a com­bo of Imfinzi with an in-house CT­LA-4 check­point dubbed treme­li­mum­ab in the MYS­TIC study that will read out soon for lung can­cer. An­a­lysts are wait­ing ea­ger­ly to see if it can beat out the com­pe­ti­tion, or get side­lined by some well-known tox­i­c­i­ty con­cerns.

One thing is ab­solute­ly cer­tain. Bris­tol-My­ers Squibb start­ed as the dom­i­nant play­er in PD-(L)1, then got checked by a surg­ing Mer­ck when it made the wrong clin­i­cal move on non-small cell lung can­cer. As­traZeneca, the last of the big 5 to land an ap­proval, just days ago stunned vir­tu­al­ly every­one with pos­i­tive Phase III da­ta for Imfinzi in un­re­sectable lung can­cer, pro­vid­ing ear­ly dom­i­nance in a sig­nif­i­cant niche mar­ket.

The Big Phar­ma’s stock soared as an­a­lysts be­gan to cal­cu­late what that is worth.

Just at a time when check­points should start get­ting more pre­dictable, the field seems to be ripe for fresh sur­pris­es of all kinds. And that will con­tin­ue to at­tract fresh waves of com­bi­na­tion stud­ies tack­ling all kinds of can­cers.

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,800+ biopharma pros reading Endpoints daily — and it's free.

His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain drugs; 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.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,800+ biopharma pros reading Endpoints daily — and it's free.

Seagen interim CEO Roger Dansey and Daiichi Sankyo CEO Sunao Manabe

Paving the way for Mer­ck­'s buy­out, Seagen los­es ar­bi­tra­tion dis­pute with Dai­ichi over ADC tech

As Seagen awaits a final buyout offer from Merck that could be in the territory of $40 billion, Seagen revealed Friday afternoon that it lost an arbitration dispute with Daiichi Sankyo relating to the companies’ 2008 collaboration around the use of antibody-drug conjugate (ADC) technology.

But that loss likely won’t matter much when it comes to Merck’s deal.

After breaking off its pact with Daiichi in mid-2015, the two companies battled over “linker” tech — a chemical bridge between an ADC’s antibody component and the cytotoxic payload — that Seagen claims Daiichi would improve upon and implement in its current generation of ADCs.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,800+ biopharma pros reading Endpoints daily — and it's free.

Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,800+ biopharma pros reading Endpoints daily — and it's free.

J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,800+ biopharma pros reading Endpoints daily — and it's free.

No­var­tis re­ports two pa­tient deaths af­ter treat­ment with Zol­gens­ma

Two children with spinal muscular atrophy have died after receiving Novartis’ Zolgensma, a gene therapy designed as a one-time treatment for the rare fatal disease.

The deaths, which resulted from acute liver failure, occurred in Russia and Kazakhstan, Novartis confirmed in a statement to Endpoints News. Having notified health authorities across all the markets where Zolgensma is available, it will update the drug label “to specify that fatal acute liver failure has been reported,” a spokesperson wrote.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,800+ biopharma pros reading Endpoints daily — and it's free.