Tough times for Tecen­triq as NICE once again slaps down Roche's im­munother­a­py — slight ben­e­fit not worth price

The UK drug-pric­ing watch­dog has again nixed Roche and its can­cer im­munother­a­py Tecen­triq.

The Na­tion­al In­sti­tute for Health and Care Ex­cel­lence’s lat­est fil­ing is for ex­ten­sive-stage small cell lung can­cer pa­tients. The reg­u­la­tor de­ter­mined that al­though Tecen­triq ap­peared to im­prove pa­tient sur­vival and qual­i­ty of life in clin­i­cal tri­als, that da­ta was un­cer­tain and based on pa­tients who were dis­sim­i­lar to the av­er­age NHS pa­tient. The ben­e­fits Roche had shown were not worth the drug’s on av­er­age £32,800 (rough­ly $43,300) price, NICE said.

It’s the sec­ond re­cent price-based re­jec­tion for Roche on the isle. In Oc­to­ber, the watch­dog re­fused to en­dorse Tecen­triq for triple-neg­a­tive breast can­cer. The Swiss gi­ant had failed to col­lect tri­al da­ta di­rect­ly com­par­ing the im­munother­a­py to cur­rent treat­ments, and NICE cast doubts on the mod­els they used to ex­trap­o­late a com­par­i­son.

The re­jec­tion is a set­back for Roche as it com­petes with As­traZeneca, Bris­tol-My­ers Squibb and in­dus­try leader Mer­ck, among oth­ers, in the ex­pand­ing PD-(L)1 mar­ket.

Tecen­triq, chem­i­cal­ly known as ate­zolizum­ab, did pass NICE’s muster as part of a com­bi­na­tion ther­a­py for non-small cell lung can­cer in June. Even then, though, it didn’t get the ring­ing en­dorse­ment Mer­ck’s Keytru­da re­ceived the year be­fore, when NICE not­ed a 16-month sur­vival ben­e­fit as a monother­a­py.

NICE based their rec­om­men­da­tions on the IM­pow­er133 tri­al that showed a com­bi­na­tion of Tecen­triq and chemother­a­py could boost pro­gres­sion-free sur­vival from 4.3 months to 5.2 months and in­crease me­di­an over­all sur­vival from 10.3 months to 12.3 months.

Un­like the breast can­cer tri­al, NICE ac­cept­ed the com­par­i­son, with­in lim­its.

The tri­al “sug­gests that ate­zolizum­ab with chemother­a­py could help peo­ple to live longer with­out their dis­ease pro­gress­ing, and to live for longer com­pared with chemother­a­py alone,” they wrote.

But they not­ed that the tri­al in­clud­ed on­ly high-per­form­ing pa­tients — those who had an ECOG score of 0-1. They said that could not be gen­er­al­ized to the pop­u­la­tion of Eng­land, where many would like­ly have a worse score. They al­so said that pro­jec­tions of the tri­al da­ta showed the place­bo and treat­ment arms al­most con­verged around month 30, cast­ing doubts on the over­all sur­vival ben­e­fit.

These ques­tions, though, ul­ti­mate­ly had lit­tle im­pact on their de­ci­sion, NICE said. The agency pro­ject­ed pa­tients would live 4.93 months longer on av­er­age with the drug and said most mod­els showed a me­di­an ben­e­fit around or over the 3-month bench­mark for end-of-life ther­a­pies.

The cost for that ben­e­fit, though, was greater than the stan­dard £50,000 per qual­i­ty-of-life-year gained.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

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A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

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Data on remdesivir — the first drug shown to benefit Covid-19 patients in a randomized, controlled trial setting — may be murky, but its maker Gilead could reap billions from the sales of the failed Ebola therapy, according to an estimate by a prominent Wall Street analyst. However, the forecast, which is based on a $5,000-per-course US price tag, triggered the ire of one top drug price expert.

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So much for a speedy review.

In February, Novartis announced that an application for their much-touted multiple sclerosis drug ofatumumab had been accepted and, with the drug company cashing in on one of their priority review vouchers, the agency was due for a decision by June.

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The White House-led initiative designed to bankroll development to bring a vaccine to the American public by this fall — Operation Warp Speed — has via BARDA handed a meaty contract to the maker of an FDA-licensed anthrax vaccine to open up its manufacturing apparatus to shore up production of Covid-19 vaccines.

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Nicholas Kartsonis had been running clinical infectious disease research at Merck for almost 2 years when, in mid-January, he got a new assignment: searching the pharma giant’s vast libraries for something that could treat the novel coronavirus.

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