As­traZeneca spells out a ma­jor drop in the risk of death for stage 3 NSCLC pa­tients tak­ing Imfinzi — and why that's im­por­tant

As­traZeneca’s top team un­der Pas­cal So­ri­ot $AZN has spent the past 5 years prov­ing that it could do se­ri­ous block­buster de­vel­op­ment work. And few tri­als have been as im­por­tant to forg­ing that rep as PA­CIF­IC, which of­fered clear ev­i­dence that its PD-L1 check­point Imfinzi al­lowed pa­tients with un­re­sectable stage 3 non-small cell lung can­cer to live longer.

Dave Fredrick­son

This morn­ing, As­traZeneca ex­ecs turned up at the World Con­fer­ence on Lung Can­cer in Toron­to to spell out the promis­ing over­all sur­vival da­ta the phar­ma gi­ant had claimed with a top-line re­port last spring. The study was pub­lished in the New Eng­land Jour­nal of Med­i­cine.

Their pre­sen­ta­tion spot­light­ed a 32% re­duc­tion in the risk of death — HR 0.68 — for these stage 3 pa­tients, while the me­di­an OS rate had yet to be hit. 

Why is a one-third drop in the risk of death that im­por­tant?

At stage 3, says Dave Fredrick­son, the head of the On­col­o­gy Busi­ness Unit at As­traZeneca, pa­tients can still hold on to a rea­son­able hope that they can be cured.

“At stage 4,” he tells me, “the 5-year sur­vival rate is be­low 10%.” Adding this ther­a­py af­ter chemora­dio­ther­a­py of­fers some ex­pec­ta­tion that they’re not nec­es­sar­i­ly fac­ing a death sen­tence and “maybe bend­ing 5-year sur­vival times.”

Re­searchers have yet to do that. Map­ping out a durable re­sponse takes some time. 

Over­all Sur­vival in the In­ten­tion-to-Treat Pop­u­la­tion. Source: NE­JM

Click on the im­age to see the full-sized ver­sion

In the mean­time, says Fredrick­son, “we have seen quite brisk up­take since we have had ap­proval in the US of the PA­CIF­IC reg­i­men.” And that is mak­ing this drug the stan­dard of care in a ma­jor niche mar­ket.

“Half of pa­tients in stage 3 are treat­ed with ra­diochemother­a­py. Half of those pa­tients are be­ing treat­ed with Imfinzi af­ter­wards,” he says, a 50% share that’s cru­cial for a com­pa­ny an­gling in be­hind Mer­ck and Bris­tol-My­ers Squibb, the two dom­i­nant gi­ants in im­muno-on­col­o­gy.

Fredrick­son adds that As­traZeneca’s de­vel­op­ment strat­e­gy gives it an 18- to 24-month win­dow ahead of the ar­rival of any ri­vals. Dur­ing that time, the R&D group is work­ing on more re­search pro­grams to see if they can take the reg­i­men to ear­li­er stages of the dis­ease, with a spe­cial tri­al in Chi­na de­signed to quick­ly break in­to that boom­ing health­care mar­ket.

The pos­i­tive re­sults for As­traZeneca on PA­CIF­IC were es­pe­cial­ly im­por­tant af­ter their PD-L1 drug failed to make the first hur­dle on MYS­TIC. OS da­ta on that study are due some­time be­fore the end of the year. And if it’s a fail­ure, as many sus­pect it is, the phar­ma gi­ant will still have PA­CIF­IC and stage 3 NSCLC to boast about.

That’s a big deal for As­traZeneca.

Sean Parker, AP

Sean Park­er helps cre­ate a CRISPRed cell ther­a­py 2.0 play — and he’s got a high-pro­file set of lead­ers on the team

You can rack up one more high-profile debut effort in the wave of activity forming around cell therapy 2.0. It’s another appealing Bay Area group that’s attracted some of the top hands in the business to a multi-year effort to create a breakthrough. And they have $85 million in hand to make that first big step to the clinic.

Today it’s Ken Drazan and the team at South San Francisco-based ArsenalBio that are coming from behind the curtain for a public bow, backed by billionaire Sean Parker and a collection of investors that includes Beth Seidenberg’s new venture investment operation based in LA.
Drazan — a J&J Innovation vet with a long record of entrepreneurial endeavors — exited the stage in 2018 when his last mission ended as he stepped aside as president of Grail. It wasn’t long, though, before he was helping out with a business plan for ArsenalBio that revolved around the work of a large group of interconnected scientists supported by the Parker Institute for Cancer Immunology.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 62,400+ biopharma pros reading Endpoints daily — and it's free.

Alice Shaw, Lung Cancer Foundation of America

Top ALK ex­pert and can­cer drug re­searcher Al­ice Shaw bids adieu to acad­e­mia, hel­lo to No­var­tis

Jay Bradner has recruited a marquee oncology drug researcher into the ranks of the Novartis Institutes for BioMedical Research. Alice Shaw is jumping from prestigious posts intertwined through Mass General, Harvard and Dana-Farber to take the lead of NIBR’s translational clinical oncology group.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 62,400+ biopharma pros reading Endpoints daily — and it's free.

Flu Virus (Source: CDC)

FDA ex­pands Xofluza ap­proval as Roche strug­gles to catch loom­ing flu mar­ket

As a potentially powerful flu season looms, so does a big test for Roche and its new flu drug, Xofluza. The Swiss giant just got a small boost in advance of that test as the FDA expanded Xofluza’s indication to include patients at high risk of developing flu-related complications.

Xofluza (baloxavir marboxil) was approved last October in the US, the first landmark flu drug approval in 20 years and a much-needed green light for a company that had watched its leading flu drug Tamiflu get eaten alive by generics. Like its predecessor, the pill offered a reduction in flu symptoms but not a cure.

EMA backs sev­en ther­a­pies, in­clud­ing Mer­ck­'s Ebo­la vac­cine

The first-ever Ebola vaccine is on the precipice of approval after the European Medicine’s Agency (EMA) backed the Merck product in this week’s roster of recommendations.

The drugmaker $MRK began developing the vaccine, christened Ervebo, during the West African outbreak that occurred between 2014 and 2016, killing more than 11,000.

The current outbreak in the Democratic Republic of Congo (DRC) has shown case fatality rates of approximately 67%, the agency estimated. Earlier this year, the WHO declared the outbreak — which so far has infected more than 3,000 people — a public health emergency of international concern.

Ronald Herb­st fol­lows Med­Im­mune ex­o­dus to Pyx­is CSO post; Jeff God­dard to suc­ceed CEO of AIT Bio­science

→ The outflow of top execs from MedImmune continues to fill the leadership ranks of smaller biotechs. The latest to take off is Ronald Herbst, the head of oncology research, who’s assuming the CSO post at Pyxis Oncology.  

Herbst was part of the old MedImmune organization AstraZeneca CEO Pascal Soriot restructured earlier this year, reorganizing the company and eliminating the storied subsidiary as a separate organization.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 62,400+ biopharma pros reading Endpoints daily — and it's free.

Mer­ck is tak­ing the ax to its US op­er­a­tions, cut­ting 500 jobs in its lat­est re­or­ga­ni­za­tion

Merck is cutting 500 jobs in its US sales and headquarters commercial teams in its latest effort to find new ways to streamline the operation.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 62,400+ biopharma pros reading Endpoints daily — and it's free.

Mi­rati preps its first look at their KRAS G12C con­tender, and they have to clear a high bar for suc­cess

If you’re a big KRAS G12C fan, mark your calendars for October 28 at 4:20 pm EDT.

That’s when Mirati $MRTX will unveil its first peek at the early clinical data available on MRTX849 in presentations at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston.

Mirati has been experiencing the full effect of a rival’s initial success at targeting the G12C pocket found on KRAS, offering the biotech some support on the concept they’re after — and biotech fans a race to the top. Amgen made a big splash with its first positive snapshot on lung cancer, but deflated sky-high expectations as it proved harder to find similar benefits in other types of cancers.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 62,400+ biopharma pros reading Endpoints daily — and it's free.

The FDA will hus­tle up an ex­pe­dit­ed re­view for As­traZeneca’s next shot at a block­buster can­cer drug fran­chise

AstraZeneca paid a hefty price to partner with Daiichi Sankyo on their experimental antibody drug conjugate for HER2 positive breast cancer. And they’ve been rewarded with a fast ride through the FDA, with a straight shot at creating another blockbuster oncology franchise.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 62,400+ biopharma pros reading Endpoints daily — and it's free.

Med­ical an­i­ma­tion: Mak­ing it eas­i­er for the site and the pa­tient to un­der­stand

Medical animation has in recent years become an increasingly important tool for conveying niche information to a varied audience, particularly to those audiences without expertise in the specialist area. Science programmes today, for example, have moved from the piece-to-camera of the university professor explaining how a complex disease mechanism works, to actually showing the viewer first-hand what it might look like to shrink ourselves down to the size of an ant’s foot, and travel inside the human body to witness these processes in action. Effectively communicating a complex disease pathophysiology, or the novel mechanism of action of a new drug, can be complex. This is especially difficult when the audience domain knowledge is limited or non-existent. Medical animation can help with this communication challenge in several ways.
Improved accessibility to visualisation
Visualisation is a core component of our ability to understand a concept. Ask 10 people to visualise an apple, and each will come up with a slightly different image, some apples smaller than others, some more round, some with bites taken. Acceptable, you say, we can move on to the next part of the story. Now ask 10 people to visualise how HIV’s capsid protein gets arranged into the hexamers and pentamers that form the viral capsid that holds HIV’s genetic material. This request may pose a challenge even to someone with some virology knowledge, and it is that inability to effectively visualise what is going on that holds us back from fully understanding the rest of the story. So how does medical animation help us to overcome this visualisation challenge?