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.”

Once fu­ri­ous over No­var­tis’ da­ta ma­nip­u­la­tion scan­dal, the FDA now says it’s noth­ing they need to take ac­tion on

Back in the BP era — Before Pandemic — the FDA ripped Novartis for its decision to keep the agency in the dark about manipulated data used in its application for Zolgensma while its marketing application for the gene therapy was under review.

Civil and criminal sanctions were being discussed, the agency noted in a rare broadside at one of the world’s largest pharma companies. Notable lawmakers cheered the angry regulators on, urging the FDA to make an example of Novartis, which fielded Zolgensma at $2.1 million — the current record for a one-off therapy.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 77,000+ biopharma pros reading Endpoints daily — and it's free.

Covid-19 roundup: GSK, Am­gen tai­lor R&D work to fit the coro­n­avirus age; Doud­na's ge­nomics crew launch­es di­ag­nos­tic lab

You can add Amgen and GSK to the list of deep-pocket drug R&D players who are tailoring their pipeline work to fit a new age of coronavirus.

Following in the footsteps of a lineup of big players like Eli Lilly — which has suspended patient recruitment for drug studies — Amgen and GSK have opted to take a more tailored approach. Amgen is intent on circling the wagons around key studies that are already fully enrolled, and GSK has the red light on new studies while the pandemic plays out.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 77,000+ biopharma pros reading Endpoints daily — and it's free.

In a stun­ning set­back, Amarin los­es big patent fight over Vas­cepa IP. And its high-fly­ing stock crash­es to earth

Amarin’s shares $AMRN were blitzed Monday evening, losing billions in value as reports spread that the company had lost its high-profile effort to keep its Vascepa patents protected from generic drugmakers.

Amarin had been fighting to keep key patents under lock and key — and away from generic rivals — for another 10 years, but District Court Judge Miranda Du in Las Vegas ruled against the biotech. She ruled that:
(A)ll the Asserted Claims are invalid as obvious under 35 U.S.C.§ 103. Thus, the Court finds in favor of Defendants on Plaintiff’s remaining infringementclaim, and in their favor on their counterclaims asserting the invalidity of the AssertedClaims under 35 U.S.C. § 103.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 77,000+ biopharma pros reading Endpoints daily — and it's free.

Covid-19 roundup: J&J, BAR­DA set ear­ly 2021 fin­ish line for $1B vac­cine race; FDA al­lows emer­gency drug use, ahead of piv­otal da­ta

J&J has zeroed in on a Covid-19 vaccine candidate that it hopes to begin testing in humans by September this year — with the extraordinary goal of getting it ready for emergency use in early 2021. And together with BARDA, it’s committing $1 billion to make it happen.

That kind of accelerated timeline would fall on the fast side of NIAID director Anthony Fauci’s well-publicized prediction that it would be another 12 to 18 months before a vaccine can be available for public use. A Phase I trial of Moderna’s mRNA vaccine began two weeks ago, and both the biotech and fellow mRNA player CureVac have discussed similar, if not even faster, timelines for emergency use among healthcare workers.

Mene Pangalos via YouTube

As­traZeneca says its block­buster Farx­i­ga proved to be a game-chang­er in CKD — wrap­ping PhI­II ear­ly

If the FDA can still hold up its end of the bargain, AstraZeneca is already on a short path to scooping up a cutting-edge win with a likely approval for their SGLT2 drug Farxiga in cutting the risk of heart failure. Now the pharma giant says it can point to solid evidence that the drug — initially restricted to diabetes — also works for chronic kidney disease, potentially adding a blockbuster indication for the franchise.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 77,000+ biopharma pros reading Endpoints daily — and it's free.

It is 'kind of a proven tech­nol­o­gy': Hep B vac­cine mak­er joins glob­al hunt for coro­n­avirus vac­cine

Using lab-grown proteins that are engineered to mimic the architecture of viruses to induce an immune response, VBI Vaccines is joining the hunt for a coronavirus vaccine — harnessing technology that has initially been proved safe in early trials as a prophylactic for cytomegalovirus (CMV) infection.

Unlike the raft of the companies in the Covid-19 vaccine race — including Moderna, CureVac and J&J — VBI is taking a pan-coronavirus approach, by developing a vaccine that will encompass Covid-19, severe acute respiratory syndrome (SARS), and Middle East respiratory syndrome (MERS).

Can a pair of top AveX­is alum­ni steer a new gene ther­a­py up­start to R&D glo­ry? 3 VCs bet $60M on it

VCs love few things more than a proven executive team when it comes to launching a new company. And now a group of A-listers has turned to a pair of top execs out of AveXis to steer the latest gene therapy player into the clinic.

The biotech is Waltham, MA-based Affinia and the two execs are Sean Nolan and Rick Modi — the former CEO and CBO respectively of AveXis, the gene therapy pioneer that fetched $8.7 billion in a sale to Novartis. Nolan has now taken the chairman’s role at Affinia while Modi moves up to the CEO post at the company.

Un­de­terred by a pan­dem­ic, Gilde Health­care rais­es their largest fund yet

When Pieter van der Meer started raising the capital for Gilde Healthcare’s fifth fund in the waning months of 2019, he had his eyes on a different chain of events that could change the healthcare system and perhaps even play to his firm’s advantage: The US presidential election.

Since raising their third fund in 2011, the 34-year-old Dutch firm had focused on value-based care. They chose late-stage biotechs that came up with new devices and delivery systems for de-risked established compounds, and when they chose preclinical biotechs, they spoke with potential pharma partners, payers and regulators to ask where and at what prices the drug made sense. As the Democratic primary became a contest over how to lower healthcare costs, it looked like a strategy that could pay off.

Daniel O'Day (AP Images)

Gilead CEO Dan O'­Day of­fers a de­tailed ex­pla­na­tion on remde­sivir ac­cess — re­as­sur­ing an­a­lysts that Covid-19 da­ta are com­ing fast

After coming under heavy fire from consumer groups ready to pummel them for grabbing the FDA’s orphan status for remdesivir — reserved to encourage the development of rare disease therapies — Gilead CEO Daniel O’Day had some explaining to do about the company’s approach to providing access to this drug to patients suffering from Covid-19. And he set aside time over the weekend to patiently explain how they are making their potential pandemic drug available in a new program — one he feels can better be used to address a growing pack of infected patients desperately seeking remdesivir under compassionate use provisions.

In addition to trying to reassure patients that they will once again have an avenue to pursue access, O’Day also reassured some analysts who had been fretting that China’s quick comeback from the coronavirus outbreak could derail its ultra-fast schedule for testing the drug in patients. The data are still expected in a few weeks, he says in the letter, putting the readout in April.

O’Day emphasizes that Gilead intends to pursue a pricing approach that will make this drug widely available — if it proves effective and safe. But no one is quite sure just what the longterm value would be, given the work being done on a variety of vaccines that may be rolled out as early as this fall — at least to the most heavily threatened groups.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 77,000+ biopharma pros reading Endpoints daily — and it's free.