BARCELONA—If this year’s ASCO meeting was “quiet,” as some contended, this year’s ESMO was anything but.
The conference, which has been gaining steam in recent years thanks to the sheer volume of oncology data proliferating in the immuno-oncology era, was arguably as significant as it's been to date, hosting a number of data presentations that marked important “firsts” in the cancer field.
Take Merck’s Keynote-522 study, for example: It was the first to examine immuno-oncology in the neoadjuvant setting for triple-negative breast cancer patients, and it came up positive. That’s big news, considering companies’ plans to move the class of PD-1/PD-L1 drugs—which so far have mainly stuck to metastatic disease—earlier in treatment.
AstraZeneca and Merck’s Lynparza scored its own No. 1 distinction, becoming the first in its class of PARP inhibitors to bring a precision medicine approach to metastatic, castration-resistant prostate cancer. In the Profound trial, it showed it could benefit patients with homologous recombination repair mutations with a performance execs deemed practice-changing.
And Bristol-Myers Squibb’s Opdivo-Yervoy combo has a first, too, with the company becoming the only drugmaker thus far to post five-year phase 3 follow-up data for a checkpoint inhibitor combo in melanoma.
But for many, the “seconds” and “thirds” may have been even more interesting than the firsts, with new data either setting drugs up to challenge established rivals—or threatening to entrench current market leaders.
As usual, no area was watched more closely than the previously untreated lung cancer field, considered to be immuno-oncology’s most lucrative market. There, all eyes were on Bristol-Myers Squibb’s attempts to make Opdivo the third in its class to score a front-line combo nod, where it would join Roche’s Tecentriq and Merck’s dominant Keytruda.
In some ways, Bristol’s Checkmate-227 study delivered; “at a high level, what CM-227 finally gives Bristol-Myers a toehold in 1L lung cancer, the lack of which has been a major black eye for the company,” Wolfe Research analyst Tim Anderson wrote in a note to clients. Investors now see the company’s Opdivo-Yervoy duo as “an approvable regimen,” Anderson wrote, noting that, “that much is almost a given.”
Still, though, Bristol’s results had “a hard time standing up against” the Keynote-189 study that skyrocketed Keytruda’s sales, thanks to results showing the Merck drug could cut patients’ death risk by half. All in all, despite Keytruda’s momentum, Anderson predicts BMS “can still pick up share”—though its rival “will be hard to unseat.”
Elsewhere in first-line lung cancer, a different in-class foe took a swing at Keytruda—and that was Roche’s Tecentriq. Looking to make Tecentriq the second monotherapy behind Keytruda approved as a front-line treatment, the Swiss drugmaker touted results from its Impower110 trial that revealed “several arguments” Roche could make to compete with Merck, SVB Leerink analyst Daina Graybosch wrote in a research note.
While she predicted uptake would “still be limited … given Merck's substantial lead,” she and her colleagues now feel that “Roche management was justified in their excitement expressed during the recent investor day and, for investors who have gotten used to an invincible Keytruda in NSCLC, these results may be jolting,” she wrote.
And then there were the ESMO results that propelled nemesis drugs into what are sure to become head-to-head market battles. In the PARP field, both Lynparza and GlaxoSmithKline’s Zejula showed they could benefit ovarian cancer patients who have already been through a round of chemo, whether or not they have BRCA mutations. But Lynparza did it in combination with Roche’s Avastin, while Zejula did it solo.
“Investors have wanted to be able to easily look at the data sets to determine who the 'winner' was, but unfortunately it’s just not that easy,” Wolfe’s Anderson wrote in a separate investor note, flagging key differences in trial design.
“How physicians choose between the two regimens from here will partly be a function of how they already treat their ovarian cancer patients,” he added, noting that those who already use Avastin in the maintenance setting will likely gravitate toward Lynparza, with others reaching for the Zejula monotherapy option.
In that case, the data battle featured a dominant player—Lynparza—and an underdog of sorts in Zejula. In the CDK 4/6 field of breast cancer drugs, the two contenders sharing the stage were both setting up challenges to Pfizer's blockbuster-and-growing Ibrance.
Novartis' Kisqali showed it could help previously untreated, post-menopausal women with HR-positive, HER2-negative breast cancer live longer, adding to an overall survival win it previously posted in pre-menopausal patients. Eli Lilly's Verzenio also proved it could extend patients' lives, but after treatment with fulvestrant, and a majority of those patients were either tough-to-treat or had aggressive disease.
In both instances, the data broke ground Ibrance hasn't, but the companies are well aware that they'll face a challenge persuading doctors to routinely look beyond the Pfizer drug.
Asked during a press briefing about doctors continuing to use Ibrance despite proof that other drugs can help patients live longer, Novartis head of global drug development John Tsai, M.D., called it a "habit" that the company will have to persuade physicians to break. “This is a differentiator for us. We hope this will convince physicians to use ribociblib going forward.”
Feel like you need a break to digest that deluge of data? You’re not alone. But don’t count on getting one; if there’s anything the past couple of years have shown industry watchers, it’s that there are more big results on the way—and soon.