Break­ing into breast can­cer, im­mune ther­apy shows wider prom­ise

The Sun News (Sunday) - - Coasting - BY NAOMI KRESGE AND TIM LOH Bloomberg

Drug­mak­ers are hon­ing in on which can­cer pa­tients will ben­e­fit from new im­mune ther­a­pies – and find­ing many more than skep­tics had thought.

For the first time, a clin­i­cal trial showed that a treat­ment with one of the new gen­er­a­tion of drugs de­signed to un­leash the body’s own im­mune sys­tem against tu­mors can help some women with the most ag­gres­sive type of breast can­cer live longer. The study was un­veiled by Roche Hold­ing at Europe’s big­gest can­cer con­fer­ence.

These medicines, led by Merck & Co.’s block­buster Keytruda, are sold for more than a dozen dif­fer­ent can­cers, and phar­ma­ceu­ti­cal com­pa­nies are ob­ses­sively work­ing to ex­pand their ap­pli­ca­tions with newer ver­sions and treat­ment cock­tails. There are some 1,300 im­mune-based treat­ments in hu­man stud­ies, ac­cord­ing to the Can­cer Re­search In­sti­tute, largely fi­nanced by drug­mak­ers angling for a chunk of a mar­ket fore­cast to ex­ceed $100 bil­lion an­nu­ally by 2024.

“This is just the tip of the ice­berg,” said Axel Hoos, on­col­ogy re­search and de­vel­op­ment chief at U.K. pharma gi­ant Glax­oSmithK­line, which is try­ing to break back into on­col­ogy af­ter sell­ing its ex­ist­ing prod­ucts to No­var­tis AG in 2015. “There’s a lit­tle bit of hype, but there’s a lot of sub­stance.”

At the Euro­pean So­ci­ety for Med­i­cal On­col­ogy’s meet­ing over the week­end, Roche dis­closed the re­sults of a study that showed one group of pa­tients whose breast tu­mors tested pos­i­tive for a pro­tein called PD-L1 lived an aver­age of 25 months when they got an im­mune ther­apy called Te­cen­triq – about 10 months longer than oth­ers who got only chemo­ther­apy.

Im­mune ther­a­pies ex­ploded onto the scene about eight years ago when Bris­tol-My­ers Squibb’s Yer­voy be­came the first medicine of its kind to ex­tend the lives of peo­ple with me­lanoma, a lethal skin can­cer. Suc­cesses in kid­ney and lung can­cers fol­lowed shortly there-


When im­mune ther­a­pies work, the ef­fect can last for years, one of the rea­sons they’re re­garded as rev­o­lu­tion­ary. But in most pa­tients, noth­ing help­ful hap­pens – even in skin and lung tu­mors where some of the most dra­matic ef­fects have been seen.

“There are some can­cers where the im­mune sys­tem just can’t rec­og­nize it,” said Mace Rothen­berg, chief de­vel­op­ment of­fi­cer for on­col­ogy at U.S. pharma gi­ant Pfizer Inc. Fly­ing un­der the body’s pro­tec­tive radar, sci­en­tists re­fer to them as “cold tu­mors.”

Com­pa­nies are start­ing to re­think their strat­egy for the tough­est cases, said Dan O’Day, Roche’s pharma chief. Test­ing pa­tients’ tu­mors for spe­cific pro­teins and genes will help iden­tify those most likely to ben­e­fit, he said.

“We want to get away from this con­cept of giv­ing can­cer im­munother­apy to 80 per­cent of the pa­tients and only half of them re­spond,” he said in an in­ter­view. “Let’s find the other treat­ment op­tions for the other pa­tient types.”

Roche’s breast can­cer study helped sup­port the idea that there are ways for doc­tors to iden­tify more can­cers that will sub­mit to im­mune ther­apy. The drug used in the study, Te­cen­triq, blocks the pro­tein called PD-L1 that ham­pers the im­mune sys­tem’s at­tack on can­cers, and only women whose tu­mors had high lev­els of the pro­tein were helped.

An­other sign­post in the search for re­spon­ders could be the sheer num­ber of mu­ta­tions in a tu­mor as a whole, O’Day sug­gested. It’s a strat­egy that may ex­tend the reach of im­mune ther­a­pies even fur­ther, as in­di­cated by stud­ies pre­sented at the con­fer­ence. Stud­ies of can­cers of the colon and rec­tum, which have been less re­spon­sive to im­mune ther­apy, showed that tu­mors with se­vere ge­netic dam­age may of­fer bet­ter tar­gets for drugs such as Bris­tol’s Op­divo and Yer­voy.

“They’re do­ing tri­als in every dif­fer­ent tu­mor that you can imag­ine,” said Richard Gaynor, re­search and de­vel­op­ment chief of Neon Ther­a­peu­tics Inc., an im­mune-on­col­ogy startup. “There will be sub­sets of pa­tients within each group that may ben­e­fit.”

And in many cases, im­mune ther­apy may need help. The ques­tion is how to nudge the body’s pro­tec­tive sys­tem to act against cer­tain tu­mors, said In­cyte Corp. Chief Ex­ec­u­tive Of­fi­cer Herve Hop­penot. His com­pany tried the strat­egy ear­lier this year, com­bin­ing its ex­per­i­men­tal epaca­do­stat with Merck’s Keytruda, and it failed.

Still, In­cyte and other drug­mak­ers are per­sist­ing in their search for ways to track down tu­mors that have eluded im­munother­apy.

“We’re scratch­ing the sur­face,” said Lu­ciano Ros­setti, head of global re­search and de­vel­op­ment for bio­pharma for Ger­many-based Merck KGaA. “We have a first wave of real ex­cite­ment.”


Dr. Sylvia Adams, who au­thored a new study on breast can­cer treat­ment, sits in an of­fice on Oct. 17 at NYU Lan­gone in mid-town Man­hat­tan. Women with an ag­gres­sive type of breast can­cer lived longer if they re­ceived im­munother­apy plus chemo­ther­apy, rather than chemo alone, a ma­jor study has found.

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