Bristol Myers rolls out 3-year mesothelioma data for Opdivo/Yervoy in first look at ESMO slate – Endpoints News

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The Op­di­vo/Yer­voy im­munother­a­py com­bo from Bris­tol My­ers Squibb has earned some skep­ti­cism over the years from re­searchers ques­tion­ing the ef­fi­ca­cy of CT­LA-4 in fight­ing tu­mors. But in ad­vanced mesothe­lioma, the com­bi­na­tion is show­ing mul­ti-year clin­i­cal ben­e­fit in a par­tic­u­lar­ly dire pa­tient pop­u­la­tion.
Af­ter a min­i­mum of three years fol­low-up, the Op­di­vo-Yer­voy com­bo con­tin­ued to beat out chemother­a­py in terms of ex­tend­ing the lives of pa­tients with un­re­sectable ma­lig­nant mesothe­lioma as a first-line ther­a­py, ac­cord­ing to up­dat­ed da­ta from the CHECK­MATE-743 study set to be pre­sent­ed Fri­day at the ES­MO vir­tu­al con­fer­ence.
Twen­ty-three per­cent of pa­tients treat­ed with the com­bo were alive at the three-year mark com­pared with 15% on chemo, Bris­tol My­ers said. Mean­while, Op­di­vo/Yer­voy con­tin­ued to show a re­duc­tion in risk of death with a me­di­an OS of 18.1 months com­pared with 14.1 months for chemo.
Mean­while, the com­bo con­tin­ued to show durable re­spons­es un­der­scor­ing those OS re­sults. At three years, 28% of re­spon­ders pre­vi­ous­ly treat­ed with Op­di­vo-Yer­voy but off ther­a­py for one year re­mained in re­sponse com­pared with 0% on chemo. Over­all, the com­bo post­ed a me­di­an du­ra­tion of re­sponse of 11.6 months com­pared with 6.7 months for chemo and an ob­jec­tive re­sponse rate that was “com­pa­ra­ble” to chemo — 39.6% to 44%, re­spec­tive­ly.
“For pa­tients with ma­lig­nant pleur­al mesothe­lioma, the prog­no­sis is gen­er­al­ly poor, with a five-year sur­vival rate of ap­prox­i­mate­ly 10%,” said Solange Pe­ters, an on­col­o­gist at the Lau­sanne Uni­ver­si­ty Hos­pi­tal in Switzer­land, in a state­ment. “In this ag­gres­sive can­cer that his­tor­i­cal­ly has had lim­it­ed treat­ment op­tions, we’ve now not on­ly seen the po­ten­tial for pa­tients to live longer with (Op­di­vo) plus (Yer­voy), but that this ben­e­fit is sus­tained at three years com­pared to treat­ment with chemother­a­py. These re­sults give us fur­ther proof of the dura­bil­i­ty of the out­comes achieved with this com­bi­na­tion.”
The Op­di­vo/Yer­voy com­bo is now ap­proved in 14 reg­u­la­to­ry zones for this in­di­ca­tion, where it re­ceived an ini­tial FDA ap­proval in Oc­to­ber. The im­munother­a­py reg­i­men was the first new sys­temic ther­a­py ap­proved to treat un­re­sectable ma­lig­nant mesothe­lioma since 2004.
The fol­low-on da­ta is the first look at Bris­tol My­ers’ planned slate at this year’s ES­MO, which starts on Fri­day. In ad­di­tion to the CHECK­MATE-743 da­ta, the drug­mak­er is rolling out more sur­vival da­ta for the Op­di­vo-Yer­voy com­bo in oth­er in­di­ca­tions and an up­date on in­ves­ti­ga­tion­al LAG-3 in­hibitor re­latlimab’s piv­otal study. There’s al­so a planned late-break­er from the Op­di­vo-Yer­voy com­bo in CHECK­MATE-649 in first-line gas­tric can­cer.
Stay tuned this week for more.
This blog post is the second in a series about accelerating the development and manufacturing of cell-based cancer therapies. In the last post, we outlined the promise and potential of immune cell therapies to treat cancer along with an overview of the central challenges that impede their broad accessibility. In this article, we take a closer look at key considerations for establishing a reliable supply chain of quality materials to ensure a robust and reproducible workflow.
Biogen is investigating the death of a 75-year-old patient potentially linked to the company’s new Alzheimer’s drug, which the FDA controversially approved via its accelerated pathway with limited evidence that the drug actually benefits those suffering from the memory wasting disease.
The company told Endpoints News in an emailed statement that it’s carefully reviewing all adverse events reports, medication error reports, and product complaints published in FDA’s Adverse Event Reporting System, “including the fatal case of a 75-year-old patient whose cause of death remains under investigation and who was diagnosed during hospitalization with cerebral edema thought to be ARIA-E. We continue to work with the reporting physician as well as global regulators to further understand the case. Alzheimer’s disease is complex, and patients affected by this devastating disease often suffer from other serious medical conditions.”
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Five months after the approval of Biogen’s Aduhelm, the bad news just keeps piling up for the Alzheimer’s drug. The confirmation yesterday of a Biogen investigation into the death of trial participant is the latest setback, but it adds to a laundry list of ongoing woes including insurance reimbursement uncertainty, dismal initial sales, a label flipflop, FDA advisory committee members resigning and outspoken researchers and public officials who continue to question the drug’s approval.
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One of the major reasons the FDA’s accelerated approval pathway receives so many accolades and so much support is that it speeds new and hopefully improved drugs to patients, usually in oncology, while confirmatory evidence on the clinical benefit can be gathered.
But a new research letter published Tuesday in JAMA Network Open raises fresh questions about the pathway, making the case that because the difference in the amount of time it takes to run the confirmatory trial vs. the pivotal trial is typically similar, the companies might as well run the equivalent of the confirmatory trial first.
Welcome to CPhI week!
Tuesday marked the opening of this year’s CPhI Global conference in Milan, Italy, in what marks its return to an onsite event for the first time since 2019.
In many ways, this year’s CPhI is different for us here at Endpoints News. We aren’t on site — as we certainly plan to be next year — so we can’t give you the inside scoop you can expect in the future. However, our team has been closely following the biggest trends from the past year and are staying abreast of what CPhI’s stable of experts are saying about the future of the industry.
Contract manufacturers are having a moment, and it hasn’t gone unnoticed by the folks at CPhI.
The organization’s annual report found that CMOs will account for four of the five top companies by manufacturing capacity in 2025. Dawn Ecker, a CPhI expert, predicts that the biologics manufacturing volume will grow 8% a year to that deadline, expanding from 2,700kL in 2020 to 3,900kL in 2025.
Nearly half of all capacity will shift from in-house manufacturing to CMOs and hybrid companies, her findings revealed, and if trends stay consistent, the big-dog contractors will have the largest capacity volume. Those four are Korea’s Samsung Biologics, Switzerland’s Lonza, WuXi Biologics, and Fujifilm Diosynth Biotechnologies.
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CPhI week is always a time each year to reflect on the manufacturing world writ large, and this year’s event is no different.
Normally, Endpoints News would be on site this week in Milan — we hired dedicated manufacturing reporter Josh Sullivan to cover events exactly like this, after all — but ongoing concerns over the pandemic have kept us homebound for now. But this week still holds a special place for us, and I thought one way to reflect on where biopharma manufacturing has gone in the past 12 months would be to hit on a few of the biggest trends and events we’ve reported on.
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Like the mechanics in a clock, pharma manufacturing often quietly ticks away until one piece of the machine hits a snag. Now, as part of its annual check-in on the industry, CPhI is highlighting a growing backlog of manufacturing inspections foreign and domestic to the US as a potentially major snag in the gears.
To battle supply chain issues, the US has encouraged an increase in domestic production, which has not been easy or consistent. Nielsen Hobbs, Informa Pharma Intelligence’s executive editor of pollicy and regulation, says the biggest challenge facing manufacturers going forward could be inspections from regulators. A hiatus has lasted over a year, as travel has been restricted, but that is overdue to end.
Although House and Senate Democrats have finally cracked their Mission: Impossible to allow the federal government to negotiate some drug prices, the negotiations will include so few drugs and have so many stipulations attached that the end result may be more of a drop in the ocean than the monsoon that drug price negotiations could’ve been.
Congress is waiting for a CBO score before officially voting, but early estimates point to about $100 billion in drug pricing savings over ten years from the deal. That’s basically the equivalent of what the pharma industry spends on DTC marketing over a decade. Or about five years of what pharma companies spend on marketing to health care professionals.
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ENDPOINTS NEWSby John Carroll & team — all the news at 11:30am ET
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