FDA rais­es ques­tions in ad­comm brief­ing docs for Roche's Po­livy la­bel ex­pan­sion

An FDA ad­vi­so­ry com­mit­tee is meet­ing on Thurs­day to weigh a po­ten­tial la­bel ex­pan­sion for Roche’s po­ten­tial block­buster Po­livy, but the agency has some con­cerns about ef­fi­ca­cy and safe­ty.

The phar­ma gi­ant will come be­fore the On­co­log­ic Drugs Ad­vi­so­ry Com­mit­tee (ODAC) on Thurs­day to dis­cuss da­ta from the Phase III Po­lar­ix tri­al, orig­i­nal­ly in­tend­ed to meet a post-mar­ket­ing re­quire­ment, and see if Po­livy can be used for pa­tients with ear­li­er lines of dif­fuse large B-cell lym­phoma (DL­B­CL).

The drug was first ap­proved back in 2019 un­der the ac­cel­er­at­ed ap­proval path­way for pa­tients with re­lapsed or re­frac­to­ry DL­B­CL, not oth­er­wise spec­i­fied (NOS), af­ter at least two pri­or ther­a­pies.

How­ev­er, FDA dropped a 104-page brief­ing doc­u­ment that il­lu­mi­nates the agency’s cur­rent con­cerns on the an­ti­body-drug con­ju­gate.

Ac­cord­ing to the reg­u­la­tor, sev­er­al con­cerns re­lat­ed to the Po­lar­ix tri­al in­clude what the agency said was a mod­est ben­e­fit of po­latuzum­ab ve­dotin (Po­livy) plus can­cer reg­i­men R-CHP over R-CHOP, an­oth­er can­cer drug reg­i­men — show­ing a haz­ard ra­tio of 0.73. As the agency not­ed, the point es­ti­mates of PFS rates at one and two years were on­ly dif­fer­ent by 4.1% and 6.5%, re­spec­tive­ly.

“The dif­fer­ence in ob­served PFS rates is mod­est, and it is ques­tion­able whether this rate of dif­fer­ence is clin­i­cal­ly mean­ing­ful,” ac­cord­ing to the doc­u­ments. FDA al­so not­ed that the PFS ben­e­fit did not trans­late over to a ben­e­fit in com­plete re­sponse (CR) rate or over­all sur­vival (OS).

Sec­ond­ly, the FDA point­ed out that while the fi­nal analy­sis in OS showed a me­di­an fol­low-up time of 39.7 months, it did not show an im­prove­ment for Po­livy + R-CHP. On top of that, the haz­ard ra­tio in the largest sub­group (DL­B­CL NOS) was 1.02 — a 2% in­creased risk of side ef­fects.

“While there is un­cer­tain­ty as­so­ci­at­ed with the point es­ti­mates due to low event rates, lack of im­prove­ment in OS, par­tic­u­lar­ly in the con­text of front­line ther­a­py for LB­CL, is a re­flec­tion of safe­ty and ef­fi­ca­cy and adds to the un­cer­tain­ties in ben­e­fit-risk,” the agency added.

Third­ly, oth­er ef­fi­ca­cy end­points tout­ed in the study have “lim­i­ta­tions,” FDA said. One of those end­points in­clud­ed the dif­fer­ence in com­plete re­sponse rate de­ter­mined by blind­ed in­de­pen­dent cen­tral re­view, or BI­CR. The agency said that the dif­fer­ence in CR rate was not sta­tis­ti­cal­ly sig­nif­i­cant in ei­ther the drug plus R-CHP arm or the drug plus R-CHOP treat­ment arm, with a p-val­ue of p=0.1557. Fur­ther, the agency said the “lack of im­prove­ment in CR rate” cre­ates more un­cer­tain­ty about the ef­fi­ca­cy of the treat­ment, es­pe­cial­ly in light of the afore­men­tioned PFS ben­e­fit.

The Phase III, which en­rolled 879 pa­tients, had 740 pa­tients en­rolled that had DL­B­CL NOS.

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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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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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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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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Take­da ax­es gene ther­a­py deal with Po­sei­da Ther­a­peu­tics amid broad­er re­think

Less than two years after Takeda inked a collaboration with Poseida Therapeutics to develop six liver-directed and hematopoietic stem cell-directed in vivo gene therapies, Takeda will end the partnership on July 30, the company confirmed to Endpoints News.

The breakup is not unexpected, coming on the heels of Takeda’s April announcement that it planned to stop discovery and preclinical work in AAV gene therapy, as well as research and preclinical work on rare hematology. A representative for Takeda confirmed that the partnership ended because of the company’s decision to stop that work.

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