Full data supporting Eli Lilly’s Cyramza in previously untreated EGFR lung cancer patients are out. But an approval would mean going up against AstraZeneca's new king, Tagrisso—and it's become an even more formidable force with a growing arsenal of clinical evidence.
Adding Cyramza to Roche’s Tarceva cut the risk of disease progression or death by 40% compared with Tarceva alone in newly diagnosed patients with metastatic EGFR-mutated non-small cell lung cancer, Lilly said Monday. The combo stalled tumor progression by 19.4 months, versus 12.4 months for Tarceva, according to phase 3 data published in The Lancet Oncology and previously presented at the American Society of Clinical Oncology annual meeting in June.
The results suggest the Cyramza-Tarceva combo “has the potential to be an important first-line treatment option” for patients with EGFR-mutated NSCLC, the study’s lead investigator, Kazuhiko Nakagawa, said in a statement.
Lilly started the Relay study to see if dual blockade of both EGFR (by Tarceva) and VEGFR (by Cyramza) could trigger better results in NSCLC patients. “The Relay data are the strongest clinical evidence to date for targeting both the EGFR and VEGFR pathways to treat this type of cancer,” Maura Dickler, VP of late-phase development at Lilly Oncology, said in a statement.
Lilly has already submitted the data to the FDA for a potential green light. If approved, it could mark Cyramza’s sixth indication after its recent nod in hepatocellular carcinoma with high levels of alpha-fetoprotein.
But in first-line EGFR-mutated NSCLC, one drug has already accrued a large—and arguably even better—pool of data to back its case.
Back in September 2017, AstraZeneca’s third-generation EGFR-TKI Tagrisso, as a single agent, showed it could keep previously untreated patients’ lung cancer progression at bay for a median 18.9 months, significantly longer than the 10.2 months posted by Tarceva and AZ’s own Iressa.
Then, at the European Society for Medical Oncology annual meeting just over a week ago, AZ came up with gold-standard survival data, showing Tagrisso extended patients’ lives by a median 38.6 months, versus 31.8 months for those older EGFR inhibitors.
While Tagrisso’s first-line use is already cleared by the FDA—and has proven a key growth driver for AZ—Cyramza is currently only allowed for those who have progressed on chemotherapy. Now, the Cyramza-Tarceva combo’s progression-free survival benefit of 19.4 months shows it can hang with Tagrisso in the front-line setting.
But there’s also the question of reimbursement. Demonstrating patients live longer could help AZ with its Tagrisso coverage talks with payers, Dave Fredrickson, AZ’s global head of the oncology business unit, told FiercePharma at ESMO. And Lilly doesn't yet have that kind of data.
In the second quarter, Cyramza sales grew by 11% year-over-year to $241.8 million, as its market share in second-line lung almost doubled in the U.S., Lilly’s CFO Josh Smiley said during a conference call in July. Meanwhile, Tagrisso racked up $784 million during the three months, representing a 14% increase that was mainly driven by first-line use.
Cyramza and Tagrisso don’t necessarily have to be opponents all the time in first-line NSCLC now that the idea of pairing EGFR with VEGFR has shown promise: A phase 2 study is examining pairing Cyramza with the AZ drug in NSCLC.