ESMO need-to-know: Keytruda misses head and neck; Tagrisso wins; plus Lilly, BMS and more

The European Society for Medical Oncology Congress mushroomed this year with a slate of closely watched research and nearly 23,000 participants.

MADRID, Spain—It’s no secret that cancer researchers are issuing new data in rapid-fire style. That’s a good thing for the European Society for Medical Oncology (ESMO), whose annual Congress analysts billed as a must-attend event this year.

Attendees must have agreed: The organization brought in almost 23,000 people for a slate of research that included some truly late-breaking data, not to mention hotly anticipated numbers from trials such as AstraZeneca’s Pacific, a win for its immuno-oncology med Imfinzi.

In the end, there was so much news it overflowed our usual publishing schedule—so we’re gathering it all right here. Here's your need-to-know news from ESMO, with updates still to come.

Merck & Co.'s Keytruda narrowly missed the mark in a head and neck cancer trial in July, failing to show it could significantly extend overall survival. And now, details of that miss are here. In a phase 3 trial, the med only extended second-line head and neck cancer patients’ lives by 8.4 months, compared with the 7.1 months achieved with standard treatment. 

PD-1 resistance is an emerging problem. What’s the solution? Combination therapies—and that’s why scientists are digging deeply into the tumor microenvironment for targets that could lead to add-on meds. And that’s the idea behind Bristol-Myers Squibb’s biomarker push—and its LAG-3 drug BMS-986016, now moving into late-stage development under the new name relatlimab.

AstraZeneca stunned the market in May with news that its PD-L1 med Imfinzi had significantly held off lung cancer progression in patients ineligible for surgery. Now we know how long that delay was. In a phase 3 trial pitting it against placebo in patients with stage 3 non-small cell lung cancer, Imfinzi kept disease at bay for 11 months in the maintenance setting. AstraZeneca called it “exciting;” one analyst said it’s “the kind of breakthrough that promises to pull upward on the I-O market size.”

Bristol-Myers Squibb smashed doubt about Opdivo and Yervoy’s utility in first-line kidney cancer on Sunday with data showing patients lived longer when treated up front with the combo, rather than with Pfizer’s standard-of-care med, Sutent. In higher-risk patients, the Opdivo-Yervoy pairing delivered a 37% reduction in the risk of death compared with Sutent, the Checkmate-214 trial found. That’s the same study BMS halted early just last week, thanks to strong interim efficacy and safety data.

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Merck & Co.’s Keytruda is now the only PD-1/PD-L1 med with data to show it can improve overall survival in the second-line bladder cancer setting. And it keeps piling it on. The company touted mature results from a phase 3 trial showing that, in patients whose disease had progressed following platinum chemo treatment, Keytruda continued to demonstrate an overall survival advantage over chemo at a median follow-up of 22.5 months.

Eli Lilly is gearing up to challenge Pfizer’s Ibrance and Novartis’ Kisqali in HR-positive, HER2-negative breast cancer, and it rolled out more positive data for candidate abemaciclib over the weekend to help it get there. Squaring off against placebo in a phase 3 study, the prospect cut the risk of disease progression or death by 46%, Lilly said.

AstraZeneca’s Tagrisso is approved to treat only a select group of lung cancer patients who've previously taken other meds. But the British drugmaker unveiled data it says showcase the “clear potential” for Tagrisso to become the new standard of care for previously untreated lung cancer patients with EGFR gene mutations. In a phase 3 study, Tagrisso cut the risk of disease progression or death by 54% when pitted against standard-of-care tyrosine kinase inhibitors Tarceva from Roche and Iressa from AstraZeneca. 

Bristol-Myers, on the hunt for expanded use of its immunotherapy Opdivo, put out new data showing the PD-1 med held off a melanoma recurrence 35% better than its sometime partner Yervoy. And it did so with a much-reduced risk of serious side effects, according to the CheckMate-238 study.

Keytruda's new combination—with Incyte’s IDO1 enzyme inhibitor epacadostat—won’t deliver its late-stage results till early next year. But in the meantime, Merck & Co. and Incyte unveiled data from a small, earlier-stage test, and it’s among the most closely monitored presentations at ESMO.

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Merck keeps piling on positive results from its own victorious Keytruda-chemo combo approach in lung cancer. The drugmaker rolled out an additional five months’ worth of data from a phase 2 study testing the immuno-oncology star alongside chemo in first-line lung-cancer patients—and showed that the pairing maintained the benefits it previously put up. Meanwhile, AstraZeneca is still licking its wounds from its July lung-cancer combo flop—and Bristol-Myers Squibb is dreading the possibility of producing a similar result with its own ongoing Opdivo-Yervoy study.

Kura Oncology shares have rocketed more than 75% after the California biotech reported it had hit the mark in a phase 2 trial of lead drug tipifarnib in head and neck cancer—before the study was fully enrolled.

Eli Lilly’s Cyramza captured headlines with a phase 3 top-line announcement in May, showing a chemo combo had topped chemo alone at staving off bladder cancer progression among patients who'd progressed through the first line of platinum-based chemotherapy. What they didn’t know was by how much—and now, Lilly has revealed that Cyramza prolonged median progression-free survival by 46%, keeping disease at bay for 4.07 months compared with placebo’s 2.76.

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Merck’s Keytruda posted updated, longer-term positive data in previously untreated stomach cancer patients—and some new data showing it could be effective for patients much later in therapy, too. The med provoked a response rate of 26%—but that number went more than twice as high for patients who had chemo added into the mix. About 69% of PD-L1 positive patients receiving a Keytruda-chemo combo responded to the regimen, as did 60% of patients in the overall Keytruda-chemo group.

Clovis Oncology may be the middle child in the new wave of ovarian cancer treatments, but it’s hoping some new data will take it to the head of the PARP class. The U.S.-based biotech rolled out details of its Ariel-3 study, which tested Rubraca (rucaparib) in 564 patients who had completed platinum chemo. As expected, the med held off the disease for more than a year, at the median, in patients with a BRCA mutation. But perhaps more important for Clovis, among all comers, the median progression-free survival time was 13.7 months, a result that has Clovis CEO Patrick Mahaffey hopeful about an expanded FDA approval.

Idera Pharmaceuticals has posted early clinical data suggesting its TLR9 agonist improves outcomes in melanoma patients who progress after treatment with checkpoint inhibitors. The 44% overall response rate in patients treated with IMO-2125 and Yervoy has emboldened Idera to move into phase 3 early next year.