Mi­nor­i­ty racial groups con­tin­ue to be dis­mal­ly rep­re­sent­ed in can­cer tri­als — study

Da­ta re­veal that dif­fer­ent racial and eth­nic groups — by na­ture and/or nur­ture — can re­spond dif­fer­ent­ly in terms of phar­ma­co­ki­net­ics, ef­fi­ca­cy, or safe­ty to ther­a­peu­tics, but this dis­par­i­ty is not nec­es­sar­i­ly ac­count­ed for in clin­i­cal tri­als. A fresh analy­sis of the last decade of US can­cer drug ap­provals sug­gests the trend con­tin­ues, ce­ment­ing pre­vi­ous re­search that sug­gests on­col­o­gy tri­als are woe­ful­ly un­der-rep­re­sen­ta­tive of the racial make­up of the re­al world.

The study, pub­lished in the jour­nal JA­MA On­col­o­gy, eval­u­at­ed 230 tri­als to see whether spon­sors re­port­ed the racial com­po­si­tion of the pa­tients en­rolled in their stud­ies, and how mi­nori­ties were rep­re­sent­ed (ver­sus their ac­tu­al pop­u­la­tion preva­lence) in clin­i­cal tri­als that led to can­cer drug ap­provals from 2008 to 2018.

Re­searchers from the Uni­ver­si­ty of British Co­lum­bia, the Uni­ver­si­ty of Texas MD An­der­son Can­cer Cen­ter, the Fred Hutchin­son Can­cer Cen­ter in Seat­tle and Bay­lor Uni­ver­si­ty found that 145 (63%) dis­closed at least one race — but a mea­ger 18 (7.8%) doc­u­ment­ed the four ma­jor races: White, Asian, Black and His­pan­ic.

Com­pared to the ac­tu­al make­up of US can­cer pa­tients — Blacks (22% of ex­pect­ed) and His­pan­ics (44% of ex­pect­ed) were un­der­rep­re­sent­ed com­pared with Whites (98% of ex­pect­ed) and Asians (438% of ex­pect­ed), the analy­sis found.

This pat­tern is con­sis­tent — even though the NIH re­quires that mi­nor­i­ty pop­u­la­tions be ap­pro­pri­ate­ly rep­re­sent­ed in clin­i­cal re­search. Cor­po­ra­tions, which car­ry the li­on’s share of drugs across the fin­ish line, are on­ly rec­om­mend­ed to shore up rep­re­sen­ta­tion by the FDA.

A study ex­plor­ing the rea­sons be­hind chron­ic un­der­rep­re­sen­ta­tion of mi­nori­ties in on­col­o­gy tri­als, pub­lished in 2016, cit­ed a sys­tem­at­ic re­view of late-stage can­cer tri­als from 1990 to 2000 and 2001 to 2010 showed that eth­nic mi­nori­ties, par­tic­u­lar­ly African-Amer­i­cans, were not ad­e­quate­ly rep­re­sent­ed.

In stud­ies con­duct­ed be­tween 2001 and 2010 that re­port­ed race/eth­nic­i­ty, re­view­ers found that 82.9% of par­tic­i­pants were White, 6.2% were African Amer­i­can, 3.3% were Asian, 2.2% were His­pan­ic, and 0.1% were Na­tive Amer­i­can. In tri­als con­duct­ed be­tween 1990 and 2000, 89% of par­tic­i­pants were White, 10.5% were African Amer­i­can, 0.4% were His­pan­ic, and 0.04% were Asian. Even though the pro­por­tion of White par­tic­i­pants de­creased across the two pe­ri­ods, Whites con­tin­ued to com­prise a large ma­jor­i­ty of par­tic­i­pants, and the pro­por­tion of African Amer­i­can par­tic­i­pants de­creased be­tween the pe­ri­ods 1990 to 2000 and 2001 to 2010, the re­searchers ex­trap­o­lat­ed. Low mi­nor­i­ty rep­re­sen­ta­tion re­sults from “pre­ventable and in­ter­linked poli­cies, prac­tices, and bar­ri­ers at the sys­tem, in­di­vid­ual, and in­ter­per­son­al lev­els,” they con­clud­ed.

The pat­tern of dis­pro­por­tion­ate en­roll­ment in tri­als test­ing treat­ments for can­cer — a dis­ease which there are pro­nounced racial and eth­nic dis­par­i­ties in in­ci­dence and mor­tal­i­ty — is es­pe­cial­ly con­cern­ing giv­en the new wave of check­point in­hibitors.

In a sep­a­rate study pub­lished this May, re­searchers found that Black pa­tients con­sti­tut­ed less than 4% of pa­tients re­cruit­ed across mul­ti­ple tri­als that sup­port­ed the ap­proval of im­mune check­point in­hibitors for lung can­cer. The dis­crep­an­cy was echoed in tri­als con­duct­ed in re­nal cell car­ci­no­ma and oth­er tu­mor types.

“The in­ad­e­quate rep­re­sen­ta­tion of mi­nor­i­ty pa­tients on im­munother­a­py clin­i­cal tri­als could per­pet­u­ate out­come dis­par­i­ty be­cause the unique bi­ol­o­gy of the host and the tu­mors from this sub­pop­u­la­tion is not ac­count­ed for as new treat­ment al­go­rithms to guide op­ti­mal use of im­munother­a­py are de­vel­oped for use in the re­al world,” the re­searchers sug­gest­ed.

Scott Gottlieb, AP Images

Scott Got­tlieb is once again join­ing a team that en­joyed good times at the FDA un­der his high-en­er­gy stint at the helm

Right after jumping on Michael Milken’s FasterCures board on Monday, the newly departed FDA commissioner is back today with news about another life sciences board post that gives him a ringside chair to cheer on a lead player in the real-world evidence movement — one with very close ties to the FDA.

Aetion is reporting this morning that Gottlieb is joining their board, a group that includes Mohamad Makhzoumi, a general partner at New Enterprise Associates, where Gottlieb returned after stepping out of his role at the FDA 2 years after he started.

Gottlieb — one of the best connected execs in biopharma — knows this company well. As head of FDA he championed the use of real-world evidence to help guide drug developers and the agency in gaining greater efficiencies, which helped set up Aetion as a high-profile player in the game.

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Deborah Dunsire. Lundbeck

UP­DAT­ED: Deb­o­rah Dun­sire is pay­ing $2B for a chance to leap di­rect­ly in­to a block­buster show­down with a few of the world's biggest phar­ma gi­ants

A year after taking the reins as CEO of Lundbeck, Deborah Dunsire is making a bold bid to beef up the Danish biotech’s portfolio of drugs in what will likely be a direct leap into an intense rivalry with a group of giants now carving up a growing market for new migraine drugs.

Bright and early European time Monday morning the company announced that it will pay up to about $2 billion to buy Alder, a little biotech that is far along the path in developing a quarterly IV formulation of a CGRP drug aimed at cutting back the number of crippling migraines patients experience each month. In a followup call, Dunsire also noted that the company will likely need 200 to 250 reps for this marketing task on both sides of the Atlantic. And analysts were quick to note that the dealmaking at Lundbeck isn’t done, with another $2 billion to $3 billion available for more deals to beef up the pipeline.

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San Diego cou­ple charged with steal­ing trade se­crets, open­ing Chi­nese biotech as DOJ crack­down con­tin­ues

A San Diego couple has been charged with stealing trade secrets from a US hospital and opening a business based off those secrets in China as the controversial industry-wide crackdown on alleged corporate espionage continues. On the same day, the Department of Justice announced they had arrested Beijing representative Zhongsan Liu for allegedly trying to obtain research visas for government recruiters.

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UP­DAT­ED: Bio­gen pulls the plug on prized IPF drug from $562M+ Stromedix buy­out

One of Biogen’s attempts to branch out has flopped as the biotech scraps a mid-stage program for idiopathic pulmonary fibrosis.

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Warts for the win: Aclar­is' lead drug clears piv­otal study

Aclaris Therapeutics has found a way to get rid of the warts and all.

The company — which earlier this month decided to focus on its arsenal of kinase inhibitors — on Monday unveiled positive data from a pivotal study testing its lead experimental drug for use in common warts.

The drug, A-101, was tested in a 502-patient study called THWART-2 — patients enrolled had one to six warts before qualifying for the trial. Patients either self-administered A-101 topical solution or a vehicle twice a week over a two-month period. A higher proportion of patients on the drug (a potent hydrogen peroxide topical solution) saw their warts disappear at day 60, versus the vehicle (p<0.0001) — meeting the main goal of the study.  Each secondary endpoint also emerged in favor of A-101, the company said.

Tower Bridge in London [Shutterstock]

#UK­BIO19: Join GSK’s Hal Bar­ron and a group of top biotech ex­ecs for our 2nd an­nu­al biotech sum­mit in Lon­don

Over the past 10 years I’ve made a point of getting to know the Golden Triangle and the special role the UK biopharma industry plays there in drug development. The concentration of world class research institutes, some of the most accomplished scientists I’ve ever seen at work and a rising tide of global investment cash leaves an impression that there’s much, much more to come as biotech hubs are birthed and nurtured.

It’s fi­nal­ly over: Bio­gen, Ei­sai scrap big Alzheimer’s PhI­I­Is af­ter a pre­dictable BACE cat­a­stro­phe rais­es safe­ty fears

Months after analysts and investors called on Biogen and Eisai to scrap their BACE drug for Alzheimer’s and move on in the wake of a string of late-stage failures and rising safety fears, the partners have called it quits. And they said they were dropping the drug — elenbecestat — after the independent monitoring board raised concerns about…safety.

We don’t know exactly what researchers found in this latest catastrophe, but the companies noted in their release that investigators had determined that the drug was flunking the risk/benefit analysis.

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Charles Nichols, LSU School of Medicine

Could psy­che­delics tack­le the obe­si­ty cri­sis? A long­time re­searcher in the field says his lat­est mouse study sug­gests po­ten­tial

Psychedelics have experienced a renaissance in recent years amid a torrent of preclinical and clinical research suggesting it might provide a path to treat mood disorders conventional remedies have only scraped at. Now a preclinical trial from a young biotech suggests at least one psychedelic compound has effects beyond the mind, and — if you believe the still very, very early hype — could provide the first single remedy for some of the main complications of obesity.

Ac­celeron drops a de­vel­op­ment pro­gram as #2 drug fails to spark func­tion­al ben­e­fits in pa­tients with a rare neu­ro­mus­cu­lar ail­ment

Acceleron is scrapping a muscular dystrophy development program underway for its number 2 drug in the pipeline after pouring over some failed mid-stage secondary data.

Gone is the ACE-083 project in patients with facioscapulohumeral muscular dystrophy. Their drug hit the primary endpoint on building muscle but flopped on key secondaries for functional improvements in patients, which execs felt was vital to the drug’s success.