While re­cent in­no­va­tions have broad­ened the chron­ic lym­pho­cyt­ic leukemia (CLL) treat­ment land­scape, pa­tients and clin­i­cians still face com­plex chal­lenges and con­tin­ue to need ad­di­tion­al treat­ment ad­vances. At Lil­ly, we are ded­i­cat­ed to de­liv­er­ing med­i­cines that help ad­dress un­met needs for peo­ple liv­ing with blood can­cer, in­clud­ing those af­fect­ed by CLL.

CLL is a form of slow-grow­ing non-Hodgkin lym­phoma that de­vel­ops from white blood cells known as lym­pho­cytes and is one of the most com­mon types of leukemias in adults.¹ CLL ac­counts for ap­prox­i­mate­ly one-quar­ter of new leukemia cas­es in the U.S., with an es­ti­mat­ed 23,690 peo­ple who will be new­ly di­ag­nosed in 2025.^1,2 The dis­ease pri­mar­i­ly af­fects old­er adults and is of­ten char­ac­ter­ized by a high­ly vari­able clin­i­cal course for pa­tients.^1,3

Over the last decade, the pace of progress in the CLL treat­ment land­scape has been re­mark­able, trans­form­ing the dis­ease from what was once a life-al­ter­ing di­ag­no­sis in­to a more man­age­able chron­ic con­di­tion that peo­ple may live with for a long pe­ri­od of time.

Tar­get­ed ther­a­py break­throughs have re­shaped the treat­ment par­a­digm al­low­ing pa­tients to man­age their dis­ease over time and achieve pro­longed pe­ri­ods of dis­ease con­trol. Co­va­lent Bru­ton ty­ro­sine ki­nase (BTK) in­hibitors were among the first to trans­form care for B-cell ma­lig­nan­cies by ir­re­versibly bind­ing to the BTK en­zyme and dis­rupt­ing sig­nal­ing path­ways crit­i­cal for dis­ease pro­gres­sion. More re­cent­ly, the de­vel­op­ment of non-co­va­lent (re­versible) BTK in­hibitors rep­re­sents a sig­nif­i­cant ad­vance­ment, that can al­low for con­tin­ued tar­get­ing of the BTK path­way even in the pres­ence of cer­tain re­sis­tance mu­ta­tions. Along­side B-cell lym­phoma 2 (BCL-2) in­hibitors, mon­o­clon­al an­ti­bod­ies, and oth­er modal­i­ties, these in­no­va­tions have helped bring much need­ed treat­ment op­tions to peo­ple liv­ing with CLL.

Yet, de­spite this progress, many pa­tients go through mul­ti­ple peaks and val­leys, and clin­i­cians face tough de­ci­sions on which op­tion to choose for those who have pro­gressed on ini­tial treat­ments.

While long-term man­age­ment of CLL has im­proved, evolv­ing treat­ment re­sis­tance and the need for ad­di­tion­al op­tions that pro­vide durable re­mis­sion and are well-tol­er­at­ed re­main un­met needs. Ad­di­tion­al­ly, as new treat­ments have evolved, there is lim­it­ed ev­i­dence avail­able to guide what is the next best treat­ment for each pa­tient. The un­cer­tain­ty that pa­tients and their health­care providers face in­di­cates there are still sub­stan­tial gaps in knowl­edge, and a con­tin­ued need for re­search.

To mean­ing­ful­ly im­prove CLL care, there is a crit­i­cal need for ev­i­dence-based guide­lines that ac­count for the in­tri­ca­cies of treat­ing re­al-world pa­tient pop­u­la­tions by study­ing ar­eas that haven’t tra­di­tion­al­ly been the fo­cus of clin­i­cal tri­als. At Lil­ly, we have de­signed clin­i­cal pro­grams to bridge some of these gaps by eval­u­at­ing ther­a­pies in dis­tinct pa­tient pop­u­la­tions and set­tings.

Our com­mit­ment to ex­pand­ing ev­i­dence has led to in­dus­try firsts, such as con­duct­ing a clin­i­cal tri­al that fo­cus­es on pa­tients with CLL not pre­vi­ous­ly in­ves­ti­gat­ed. Oth­er stud­ies in our blood can­cer pro­gram seek to solve unan­swered ques­tions around nov­el com­bi­na­tions and un­der­stand pat­terns of re­sis­tance mu­ta­tions to em­pow­er health­care providers and pa­tients in their treat­ment choic­es and max­i­mize their out­comes. By gen­er­at­ing new da­ta in these new­er ar­eas of re­search, we aim to pro­vide physi­cians with the in­for­ma­tion need­ed to op­ti­mize treat­ment de­ci­sions to meet pa­tients where they are on their jour­ney.

As part of our work in gen­er­at­ing new ev­i­dence, we are ad­vanc­ing mean­ing­ful treat­ments that ad­dress crit­i­cal un­met needs where op­tions are lim­it­ed and out­comes are poor for peo­ple liv­ing with blood can­cer. Our ap­proach in many can­cer types, in­clud­ing CLL, cen­ters on cre­at­ing med­i­cines that tar­get high con­fi­dence ar­eas of can­cer bi­ol­o­gy, show un­equiv­o­cal ear­ly signs of clin­i­cal ac­tiv­i­ty and over­all mat­ter to pa­tients. We are fo­cused on de­vel­op­ing in­no­v­a­tive med­i­cines that not on­ly ad­dress the un­der­ly­ing dis­ease but al­so fit in­to pa­tients’ dai­ly lives by pri­or­i­tiz­ing tol­er­a­bil­i­ty and ad­min­is­tra­tion needs.

“Work­ing in the hema­tol­ogy/on­col­o­gy space for over 25 years, in clin­i­cal prac­tice and now at Lil­ly, I’ve seen first­hand how far the field has come thanks to the work of doc­tors, nurs­es, re­searchers and pa­tients. Yet, peo­ple with CLL still re­lapse, so it re­mains im­por­tant for us to con­tin­ue ad­vanc­ing the sci­ence and con­tribut­ing along­side oth­ers in the blood can­cer com­mu­ni­ty to chang­ing the nat­ur­al his­to­ry of this dis­ease,” said John Pagel, M.D., Ph.D., Se­nior Vice Pres­i­dent, Clin­i­cal De­vel­op­ment, Glob­al Head, Hema­tol­ogy, at Eli Lil­ly and Com­pa­ny. “I’m proud to be part of a team ded­i­cat­ed to bring­ing for­ward op­tions in CLL backed by ev­i­dence that can help pa­tients and their care teams nav­i­gate treat­ment choic­es and im­prove out­comes.”

Col­lab­o­ra­tion re­mains a cor­ner­stone of our progress. Lil­ly part­ners with aca­d­e­mics, clin­i­cians, and in­dus­try peers to ac­cel­er­ate the pace of in­no­va­tion and en­sure that break­throughs in sci­ence trans­late in­to mean­ing­ful ben­e­fits for peo­ple liv­ing with blood can­cer. In par­al­lel, we are work­ing with ad­vo­ca­cy or­ga­ni­za­tions and di­rect­ly with the blood can­cer com­mu­ni­ty to gath­er in­sights, raise aware­ness of un­met needs in blood can­cer through fund­ing re­search, ed­u­ca­tion and sup­port ser­vices to ad­dress chal­lenges pa­tients and care­givers face with the goal to im­prove over­all well­be­ing.

At Lil­ly, we are writ­ing the next chap­ter in CLL care by gen­er­at­ing new ev­i­dence to an­swer crit­i­cal ques­tions and pro­vid­ing physi­cians with in­no­v­a­tive, clin­i­cal­ly proven med­i­cines that can make a dif­fer­ence for peo­ple liv­ing with blood can­cer dur­ing their treat­ment jour­ney.

Ref­er­ences

1. Mukka­mal­la SKR, Tane­ja A, Maliped­di D, et al. Chron­ic Lym­pho­cyt­ic Leukemia. . Stat­Pearls . Trea­sure Is­land (FL): Stat­Pearls Pub­lish­ing; 2023 Jan. Avail­able from: https://www.ncbi.nlm.nih.gov/books/NBK470433/
2. NCI SEER Pro­gram . Can­cer Stat Facts: Leukemia—Chron­ic Lym­pho­cyt­ic Leukemia (CLL). Ac­cessed on Sep­tem­ber 3, 2025. https://seer.can­cer.gov/stat­facts/html/clyl.html
3. Qor­ri B, Geraci J, Tsay M, Cum­baa C, Alphs L, Pani L. Re­veal­ing het­ero­gene­ity in chron­ic lym­pho­cyt­ic leukemia: AI-dri­ven in­sights in­to ag­gres­sive and in­do­lent dis­ease sub­types. Jour­nal of Clin­i­cal On­col­o­gy. 2024;42(16_sup­pl). doi:10.1200/jco.2024.42.16_sup­pl.e19029

The UK gov­ern­ment on Mon­day an­nounced a ma­jor drug pric­ing deal with the White House in which the UK will pay bil­lions more pounds for med­i­cines in ex­change for a re­prieve from phar­ma tar­iffs on US-bound ex­ports for three years.

Ne­go­ti­a­tions on the UK-US trade deal have been on­go­ing since at least Oc­to­ber. US trade en­voy Jamieson Greer was in Lon­don on Nov. 24 to fi­nal­ize the terms of the deal.

As part of the arrange­ment, the UK gov­ern­ment will raise its cost-ef­fec­tive­ness thresh­old for new drugs by 25%. That thresh­old de­ter­mines whether the UK’s Na­tion­al In­sti­tute for Health and Care Ex­cel­lence (NICE) will rec­om­mend a new drug to the NHS, and has been un­changed for two decades. In essence, NICE will be able to rec­om­mend more drugs that would have been pre­vi­ous­ly re­ject­ed be­cause they were be­lieved to be too ex­pen­sive.