Roche made a splash at the American Society of Clinical Oncology (ASCO) annual meeting three years ago with data showing its Alecensa could top Pfizer’s Xalkori at keeping ALK-positive lung-cancer at bay. This time, it’s back with long-term data showing it can best Xalkori at keeping patients alive, too.
At the five-year mark, 62.5% of previously untreated patients taking Alecensa were still alive, versus just 45.5% of the Xalkori group, Roche said ahead of ASCO's virtual annual meeting. That’s a mark Alan Sandler, global head of oncology product development for solid tumors at Roche’s Genentech, called “remarkable.”
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In terms of just how long Alecensa can keep people alive, the data aren’t yet mature, and follow-up will continue until enough data accumulate to make the call. Still, the new showing—from the phase 3 Alex study—is “really the first real look that we’ve been able to take at survival,” Sandler said, calling it “the ultimate endpoint” and one that’s “deeply important” for physicians.
In this case, it’s “just further evidence that what they’ve been doing is correct, and for those few who are not, maybe this gives them another reason to be using Alecensa,” he said.
Survival data are also important to payers, and, in some markets, they’re “critical for strong reimbursement,” said Cathi Ahearn, vice president of global product strategy for Genentech’s oncology business. “The more evidence that we can provide that this is providing benefit for patients, the stronger our evidence base becomes,” she added.
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The data follow a 2017 showing in which Alecensa proved it could beat Xalkori at cutting down the risk of disease worsening or death by more than 53%. The drug went on to win a front-line FDA nod that set up a head-to-head battle in the marketplace, where Alecensa racked up CHF 268 million ($276.5 million) in the first quarter versus Xalkori’s $149 million.
That presentation also unveiled a benefit in patients with brain metastases that was echoed in Wednesday’s results. In patients with central nervous system metastases, Alecensa spurred a 42% death reduction compared with Xalkori.
In brain metastases, there’s “clear evidence that it does work,” Sandler said of the drug.