FDA OKs Bristol Myers Squibb's Lag-3 drug, approving first new class of checkpoint inhibitor in 8 years – Endpoints News

For the first time in nearly a decade, the FDA has approved a new type of checkpoint inhibitor to treat certain patients with cancer.
The drug, developed by Bristol Myers Squibb and known as relatlimab, is approved for patients with metastatic melanoma or melanoma that can’t be treated with surgery. It’s given in combination with Opdivo, Bristol’s blockbuster PD-1 inhibitor.
Marketed as Opdualag, the antibody combo will cost $27,389 per infusion. A Bristol spokesperson said the price is in line with other combination treatments for metastatic melanoma.
Relatlimab is notable because it has the same principle mechanism of action — known as checkpoint blockade —as blockbuster CTLA-4 and PD-1 immunotherapies, such as Yervoy and Keytruda. But it goes after a new target on T cells, called Lag-3.
It’s the first new checkpoint target to reach patients since the first PD-1 drugs were approved in 2014. Researchers hope it could be the beginning of a series of new immunotherapy targets that improve responses to and expand the use of checkpoint therapies, although they caution that the field has faced more than its share of failures in recent years.
Like the two previous class of drugs, relatlimab is designed to take the brakes off the immune system, unleashing it to attack tumors. Bristol Myers showed it could do so in a pivotal trial of 714 Stage III and Stage IV melanoma patients, notably without triggering untoward side effects.
The study randomized patients to receive either a combination of Opdivo and relatlimab or Opdivo alone. Patients who received the combination went a median of 10.1 months before their cancers progressed, compared to 4.6 months for Opdivo alone.
The progression data is similar to what researchers see when they combine Opdivo and Yervoy, Bristol Myers’ CTLA-4 inhibitor, but that combination can be highly toxic, leaving oncologists to only prescribe it for a subset of patients.
Relatlimab, though, showed comparatively few adverse events. The most common were elevated liver enzymes and fatigue, each of which occurred in just over 1% of patients.
That means oncologists can now prescribe Lag-3/PD-1 for patients who are too sick or otherwise don’t want to handle the side effects of CTLA-4. Executives and other researchers caution, though, that they will need more and longer-term data before concluding the Lag-3 combo is the new standard of care.
If future survival data for Lag-3 combo look similar to the CTLA-4 combo, it would reinforce “as the new standard of care for previously untreated patients with advanced melanoma,” two UK cancer researchers wrote in an New England Journal of Medicine editorial. “It is unlikely that there will be a head-to-head trial between the two combinations, since the difference in toxic effects is stark.”
Bristol Myers is now running additional trials testing Lag-3 in lung, colon and other cancers in hopes that it will also prove effective there. However, some experts doubt it will prove effective in many other cancer types and companies developing rival Lag-3 drugs, such as Regeneron, have concentrated their efforts on skin cancer.
“My understanding of what’s been at least publicly released is there’s not a slam dunk indication, where you get the same kick in activity, as melanoma,” Israel Lowy, Regeneron’s head of oncology, told Endpoints News in January.
Miriam Merad, head of Mount Sinai’s Precision Immunology Institute, agreed, telling Endpoints at the time: “I think it’s going to be very tumor specific.”
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Dozens of Yale faculty called on the university late Thursday to reinstate a suspended colleague they claim is being unfairly targeted by the Department of Justice’s ostensibly defunct “China Initiative.”
Yale professors at its Department of Cell Biology and Stem Cell Center released a lengthy statement on social media Thursday afternoon, voicing support for biologist Haifan Lin and asking for his reinstatement. Lin had reportedly come under investigation after allegations of fraud by the NIH in 2019.
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RNAi therapeutics juggernaut Alnylam Pharmaceuticals on Thursday announced that it’s suing and seeking money from both Pfizer and Moderna regarding their use of Alnylam’s biodegradable lipids, which have been integral to the way both companies’ mRNA vaccines work.
The suits, filed in the Delaware district court, both seek “fair compensation for use of its technology” but “no less than a reasonable royalty.” And if successful, the biotech will dip into two of the richest revenue streams the biopharma industry has ever seen.
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Apellis Pharmaceuticals took a beating last September after data from two Phase III studies showed conflicting data over whether its eye disease drug worked in a closely-watched indication. But Wednesday, the biotech followed up with long-term results that have investors cheering a bit louder.
In a cutout of 18-month follow-up data, Apellis revealed its drug pegcetacoplan remained durable for patients dosed monthly and once every two months. The results came back statistically significant in both studies as well, including in the Phase III trial that missed 12-month significance in September.
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Pfizer’s multi-billion-dollar, lifesaving Covid-19 vaccine will likely hold onto the record for most medical product sales for a long time coming. And those newfound billions mean plenty of things to celebrate for CEO Albert Bourla, who may end up taking home almost $50 million in compensation in 2021 and 2022.
According to an SEC filing Friday, Bourla is set to collect $24.3 million in compensation for his work leading the Big Pharma behemoth last year, and another $24.7 million in 2022 (pending the company stock price, among other factors) — on top of the more than $21 million he made in 2020.
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Leen Kawas, the startup founder and CEO who united investors behind a darkhorse approach to treating Alzheimer’s before resigning last year in a data manipulation scandal, is back.
Kawas and billionaire private equity investor Richard Kayne announced on Friday the launch of Propel Bio, a new investment firm focused on “companies at various stages across the life science space.”
The pair offered few other details about the new firm, and a spokesperson said that neither would speak on the record or comment beyond the release “to comply with SEC regulations.” An SEC filing Friday indicated the company planned to raise $150 million, but did not list any funds raised to date.
AstraZeneca’s top researcher Mene Pangalos signaled that the company may cut away from submitting its Covid-19 vaccine to the US FDA for approval, citing months of discussions with the regulator.
“We don’t need to push it in places we are not needed or wanted,” Pangalos told the Financial Times on Thursday. “If we don’t end up submitting it for a BLA [biologics license application], I don’t think it will have an impact around the world.”
Moderna late last night one-upped its Covid-19 vaccine competitor Pfizer, applying not just for another booster shot for the elderly, as Pfizer did earlier this week, but for the entire adult population.
This amendment to its EUA would allow for a fourth dose of Moderna’s Spikevax vaccine in adults 18 years and older who have received an initial booster of any authorized or approved Covid vaccine.
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Is Merck ready to crack open a major new market for its PD-1 star?
The pharma giant said so as it released full data from the Phase III KEYNOTE-091 study, which tested Keytruda against placebo as an adjuvant treatment for a group of patients with stage IB-IIIA non-small cell lung cancer.
Keytruda, when given after surgical resection of tumor, met the co-primary endpoint of disease-free survival regardless of PD-L1 expression, cutting the risk of disease recurrence or death by 24% (HR=0.76, p=0.0014). But inexplicably, the other co-primary endpoint — which focuses on a subgroup of patients whose tumors express PD-L1, as measured by tumor proportion score ≥50% — was not statistically significant (HR=0.82, p=0.14).
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