FDA ax­es di­ag­nos­tic re­quire­ment for Lil­ly's Verzenio + en­docrine ther­a­py in cer­tain breast can­cer pa­tients

In the fall of 2021, when the FDA first au­tho­rized Eli Lil­ly’s CD4/6 in­hibitor Verzenio plus en­docrine ther­a­py in ear­ly-stage HR-pos­i­tive, HER2-neg­a­tive breast can­cer and at high risk of re­cur­rence, the drug gi­ant was lim­it­ed in that pa­tients had to have a Ki-67 score — a di­ag­nos­tic test and stain­ing tech­nique that has been cor­re­lat­ed to a worse prog­no­sis in breast can­cer pa­tients — of at least 20%.

On Fri­day, FDA an­nounced that the Ki-67 score re­quire­ment was lift­ed, ex­pand­ing Lil­ly’s po­ten­tial pa­tient pop­u­la­tion.

The reg­u­la­to­ry agency said the de­ci­sion was based on re­sults from the monar­chE tri­al, the one that got Lil­ly the 2021 ap­proval.

The tri­al en­rolled thou­sands of pa­tients in­to two co­horts. The first co­hort re­quired pa­tients to have at least four patho­log­ic ax­il­lary lymph nodes (or pALN) or 1-3 pALN plus a grade 3 tu­mor, or a tu­mor size of at least 50 mil­lime­ters. The sec­ond re­quired that pa­tients not be el­i­gi­ble for co­hort 1, must have 1-3 pALN and a Ki-67 score of at least 20%.

From there, pa­tients were ran­dom­ized to ei­ther two years of Verzenio plus physi­cian’s choice of en­docrine ther­a­py, or en­docrine ther­a­py alone.

FDA wrote that a sta­tis­ti­cal­ly sig­nif­i­cant dif­fer­ence was seen in the in­tent-to-treat pop­u­la­tion, pri­mar­i­ly be­cause of the pa­tients in co­hort 1, which com­prised 91% of the study pop­u­la­tion. The agency al­so not­ed that the in­di­ca­tion is re­strict­ed to co­hort 1 — as co­hort 2 saw more deaths in pa­tients on both Verzenio and stan­dard en­docrine ther­a­py com­pared to en­docrine ther­a­py alone (10/253 vs. 5/264).

Lil­ly said in a state­ment that the ex­pan­sion was backed by four-year da­ta from the monar­chE tri­al, which showed a 6.9% dif­fer­ence be­tween the tri­al’s treat­ment groups in in­va­sive dis­ease-free sur­vival, the tri­al’s pri­ma­ry end­point.

“At four years, 85.5% of pa­tients re­mained re­cur­rence-free with Verzenio plus ET, com­pared to 78.6% with ET alone,” Lil­ly said, not­ing that the ab­solute dif­fer­ences be­tween the treat­ment groups at two and three years were 3.1% and 5.0%, re­spec­tive­ly.

On­col­o­gist and monar­chE in­ves­ti­ga­tor Eri­ka Hamil­ton praised the de­ci­sion, say­ing in a state­ment that “the ini­tial Verzenio FDA ap­proval in ear­ly breast can­cer was prac­tice-chang­ing and now, through this in­di­ca­tion ex­pan­sion, we have the po­ten­tial to re­duce the risk of breast can­cer re­cur­rence for many more pa­tients, re­ly­ing sole­ly on com­mon­ly uti­lized clin­i­co­patho­log­ic fea­tures to iden­ti­fy them.”

Orig­i­nal­ly, the In­di­ana drug gi­ant ran a sub­group analy­sis in the monar­chE tri­al on pa­tients uti­liz­ing the di­ag­nos­tic, show­ing that the com­bo of Verzenio and en­docrine ther­a­py dis­played a 37% re­duc­tion of re­cur­rence events in pa­tients with a Ki-67 score of at least 20. How­ev­er, a pan­el of breast can­cer ex­perts in late 2020 had pre­vi­ous­ly slammed the test as hav­ing a “lack of an­a­lyt­i­cal va­lid­i­ty” due to po­ten­tial out­side fac­tors that can im­pact the re­sult. Those ex­perts lat­er said that Ki-67 should be re­served on­ly in the case of very low scores (less than or equal to five) or very high scores (at least 30) in spe­cif­ic in­stances.

Image courtesy of The Janssen Pharmaceutical Companies of Johnson & Johnson.

Pro­tect­ing the glob­al phar­ma­ceu­ti­cal in­no­va­tion ecosys­tem – what’s at stake?

We are living in a new era of healthcare that is rapidly advancing progress impacting patient outcomes and experiences. We’ve seen a remarkable pace of transformational innovation, applied research, and advanced clinical development over the last decade.

Despite this tremendous progress, there is much more work to be done, and patients are counting on us – now more than ever – to continue that momentum. At the heart of our industry is a focus on developing and delivering medicines for some of the world’s most challenging diseases, including those that have few or no effective treatments today.

Roger Perl­mut­ter lines up deals, fresh fund­ing at Eikon; Sec­ond RSV vac­cine ap­proved; Sev­er­al biotechs flash­ing red; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

As you come back to our website this weekend for ASCO news, don’t forget to check out our updated event lineup at BIO, which will cover everything from the current state of VC investing in biotech to top pharma R&D chiefs discussing how to make pipeline decisions.

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Peter van de Sande, Synaffix CEO

Lon­za shells out $107M cash to snap up Synaf­fix and its ADC plat­form

After lining up a string of partnerships over the years, Dutch antibody-drug conjugate specialist Synaffix has found a new home: Lonza, the contract development and manufacturing giant.

Lonza is paying about $107 million (€100 million) in cash to acquire Synaffix, with up to $64 million (€60 million) in “additional performance-based consideration” on the table. Synaffix’s ADC tech platform will now become part of Lonza’s offering for biopharma clients, lending its bioconjugate technologies to not just ADCs but also targeted gene therapy, immune cell engagers and other applications.

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Full TIG­IT da­ta from Gilead, Ar­cus show low­er PFS rates than De­cem­ber read­out: #AS­CO23

CHICAGO — Gilead and Arcus unveiled a fuller snapshot of a Phase II study testing their experimental cancer immunotherapy combo that showed lower progression-free survival rates than its previous update, results that are likely to spark further debate over the closely-watched clinical trial.

Last December, the anti-TIGIT/anti-PD-L1 combo, positioned as a first-line treatment for non-small cell lung cancer, recorded data that drew mixed reactions. The latest analysis, presented Saturday afternoon at ASCO, included only a handful more patients than the previous update, but PFS rates fell — in one cohort by nearly three months.

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Bris­tol My­er­s' Op­di­vo keeps can­cer at bay in more lym­phoma pa­tients than Seagen's Ad­cetris in PhI­II: #AS­CO23

CHICAGO — In a study pitting Seagen’s Adcetris against Bristol Myers Squibb’s Opdivo in newly diagnosed patients with advanced classic Hodgkin lymphoma, a greater proportion of those who received Opdivo saw no cancer growth at one year compared to those who got Adcetris.

In addition, patients in the Opdivo arm of the Phase III trial reported reduced toxicities, according to lead investigator Alex Herrera, a hematologist-oncologist at City of Hope’s cancer cancer in Duarte, CA. Notably, the trial included more than 200 children across both arms. Generally, more than half of children with advanced Hodgkin lymphoma receive radiation therapy, but in this trial, dubbed SWOG S1826, only a handful of patients in the two arms received radiotherapy, sparing many children from long-term side effects of radiation.

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Servi­er’s vo­rasi­denib stalls pro­gres­sion of brain can­cer by 61% in piv­otal PhI­II IN­DI­GO study: #AS­CO23

An experimental pill from Servier Pharmaceuticals showed potentially practice-changing results in a narrow group of brain cancer patients, cutting the risk of their cancers progressing by 61%, according to a late-stage clinical trial.

The drug, vorasidenib, is a precision medicine that only works in certain people whose cancer carries mutations in one of two genes called IDH1/2. Doctors hope that the therapy will delay the need for chemotherapy or radiation, which are often used to combat relapses in patients who’ve previously undergone surgery to remove brain tumors.

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GSK pro­motes rou­tine im­mu­niza­tions for adults amid post-pan­dem­ic vac­cine back­slide

GSK launched a new initiative on Thursday and committed up to $1 million in grant funding to improve adult routine vaccination rates.

While the pandemic spotlight was trained on the race for novel Covid-19 vaccines, other routine vaccination rates plummeted, raising concerns that missed doses may put children and even some adults at risk of preventable diseases such as measles or shingles. The World Health Organization last year reported the largest drop in childhood vaccinations in roughly three decades.

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Tammie Denyse speaks up about Black women and breast cancer inequity in Gilead's first TikTok campaign. (Gilead Sciences)

Gilead joins Tik­Tok with on­col­o­gy aware­ness cam­paign fea­tur­ing di­verse group of can­cer ad­vo­cates

Gilead Sciences is taking over the opening page on TikTok for the next two weeks. A Gilead-sponsored video, featuring cancer advocates talking about equity and other issues, will show up as the landing page, called the “For You” page, for millions of TikTok watchers.

The cancer awareness campaign will begin on Monday and run for two weeks, a Gilead spokesperson told Endpoints News. The TikTok ad debut is timed around the ASCO medical conference, but the work is aimed more broadly at healthcare professionals, as well as people touched by cancer and people interested in advancing Black and general health equity.

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Stephen MacMillan, Hologic CEO (Photo by Riccardo Savi/Getty Images for Concordia Summit)

Il­lu­mi­na names Ho­log­ic CEO as new board mem­ber and chair

Illumina’s board appointed two new members, including Hologic CEO Stephen MacMillan as the non-executive chair, a move that followed a proxy fight that saw shareholders oust the company’s board chair.

The DNA sequencing company also appointed Scott Ullem, the CFO of Edwards Lifesciences, to the board, according to a company statement.

Illumina’s plans to add two new board members came as Carl Icahn waged a board proxy campaign culminating with shareholders electing his candidate, Andrew Teno, over board chair John Thompson. Illumina CEO Francis deSouza survived a threat to his board seat by securing more than twice the shareholder votes than his challenger. Another Illumina candidate, Robert Epstein, was also elected and remained on the board.

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