Study: Im­mune ther­apy scores win against lung can­cer


CHICAGO — For the first time, a treat­ment that boosts the im­mune sys­tem greatly im­proved sur­vival in peo­ple newly di­ag­nosed with the most com­mon form of lung can­cer. It’s the big­gest win so far for im­munother­apy, which has had much of its suc­cess un­til now in less com­mon can­cers.

In the study, Merck’s Keytruda, given with stan­dard chemo­ther­apy, cut in half the risk of dy­ing or hav­ing the can­cer worsen, com­pared to chemo alone af­ter nearly one year. The re­sults are ex­pected to quickly set a new stan­dard of care for about 70,000 pa­tients each year in the United States whose lung can­cer has al­ready spread by the time it’s found.

An­other study found that an im­munother­apy combo — the Bris­tol-My­ers Squibb drugs Op­divo and Yer­voy — worked bet­ter than chemo for de­lay­ing the time un­til can­cer wors­ened in ad­vanced lung can­cer pa­tients whose tu­mors have many gene flaws, as nearly half do. But the ben­e­fit lasted less than two months on av­er­age and it’s too soon to know if the combo im­proves over­all sur­vival, as Keytruda did.

All of these im­mune ther­apy treat­ments worked for only about half of pa­tients, but that’s far bet­ter than chemo has done in the past.

“We’re not nearly where we need to be yet,” said Dr. Roy Herbst, a Yale Can­cer Cen­ter lung ex­pert who had no role in the stud­ies.

Re­sults were dis­cussed Mon­day at an Amer­i­can As­so­ci­a­tion for Can­cer Re­search con­fer­ence in Chicago and pub­lished by the New Eng­land Jour­nal of Medicine. The stud­ies were spon­sored by the drug­mak­ers, and many study lead­ers and Herbst con­sult for the com­pa­nies.


Keytruda, Yer­voy and Op­divo are called check­point in­hibitors. They re­move a cloak that some can­cer cells have that hides them from the im­mune sys­tem. The drugs are given through IVs and cost about $12,500 a month.

Keytruda was ap­proved last year as an ini­tial treat­ment with chemo for the most com­mon form of ad­vanced lung can­cer, but doc­tors have been leery to use it be­cause that was based on a small study that did not show whether it pro­longs life.

The new study, led by Dr. Leena Gandhi of NYU’s Perl­mut­ter Can­cer Cen­ter, gives that proof. In it, 616 pa­tients were given chemo and some also re­ceived Keytruda. Those not given Keytruda were al­lowed to switch to it if their can­cer wors­ened.

Af­ter one year, 69 per­cent of peo­ple orig­i­nally as­signed to Keytruda were alive ver­sus 49 per­cent of the oth­ers — a re­sult that ex­perts called re­mark­able con­sid­er­ing that the sec­ond group’s sur­vival was im­proved be­cause half of them wound up switch­ing.

How much it ul­ti­mately will ex­tend life isn’t known — more than half in the Keytruda group are still alive; me­dian sur­vival was just over 11 months for the oth­ers.

The Keytruda combo also de­layed the time un­til can­cer wors­ened — an av­er­age of nine months ver­sus five months for the chemo-only group.

That’s a big dif­fer­ence for such an ad­vanced can­cer, said Dr. Al­ice Shaw, a Mas­sachusetts Gen­eral Hos­pi­tal lung can­cer ex­pert and one of the con­fer­ence lead­ers. “This is re­ally a piv­otal study . . . a new stan­dard of care,” said Shaw, who has no ties to the drug­mak­ers.

Rates of se­ri­ous side ef­fects were sim­i­lar, but twice as many in the Keytruda group dropped out be­cause of them. More than 4 per­cent of that group de­vel­oped lung in­flam­ma­tion and three pa­tients died of it.


Dr. Matthew Hell­mann of Memo­rial Sloan Ket­ter­ing Can­cer Cen­ter in New York led a study test­ing the Op­divo-Yer­voy combo ver­sus chemo in a slightly dif­fer­ent group of newly di­ag­nosed ad­vanced lung can­cer pa­tients.

The study de­sign was changed af­ter it was un­der­way to look at re­sults ac­cord­ing to pa­tients’ tu­mor mu­ta­tion bur­den — a mea­sure of how flawed their can­cer genes are, ac­cord­ing to a pro­fil­ing test by Foun­da­tion Medicine. Medi­care re­cently agreed to cover the $3,000 test for ad­vanced can­cers.

Of 679 pa­tients, 299 had a high num­ber of gene flaws in their tu­mors. In that group, sur­vival with­out wors­en­ing of dis­ease was 43 per­cent af­ter one year for those on the im­munother­apy drugs ver­sus 13 per­cent of those on chemo. The im­munother­apy drugs did not help peo­ple with fewer tu­mor gene flaws.

“We have a tool that helps us de­ter­mine who are the pa­tients that are most likely to ben­e­fit from this com­bi­na­tion,” Hell­mann said.

The me­dian time un­til can­cer wors­ened was about 7 months on the im­munother­apy drugs ver­sus 5.5 months for chemo. Se­ri­ous side ef­fects were a lit­tle more com­mon in the chemo group.

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