In early cancer thats amenable to surgery, a field viewed as the next battleground for PD-1\/L1 immunotherapies, Roches Tecentriq has claimed the first post-operative win innon-small cell lung cancer. But the drugs role, at least in some patients, remains unclear.<\/p>\n
Tecentriq slashed the risk of cancer recurrence or death after surgery by 34% in a studyslated for the virtual American Society of Clinical Oncology meeting next monthbut onlyin patients with stage II to IIIA disease whose tumors bore the PD-L1 biomarker.<\/p>\n
Charles Fuchs, M.D., head of oncology andhematology product development at Roches Genentech, called the win a transformative step in helping patients with early-stage lung cancer.<\/p>\n
Historically, improving a disease-free survival by 20% or 30% has been practice-changing and really meaningful when youre talking in a curative setting, Fuchs said in an interview.<\/p>\n
But when all patients in the IMpower010 studyare counted, the number drops to 19%raising questions about how broad an FDA approval might be and whether doctors would actually use the drug for post-surgeryNSCLC.<\/p>\n
Plus, the 34% recurrence reduction rate Tecentriq achieved in the carved-out subgroup was way lower than the 83% AstraZenecas small-molecule drug Tagrisso accomplished in patients with EGFR-mutated stage II to IIIA disease in its own phase 3 Adaura trial. <\/p>\n
While Tagrisso targets a niche population, physicians are benchmarking their interest in Tecentriqs post-surgery adjuvant use against the EGFR inhibitor data right now, becausedata hasntyet shownwhether either drug can help patients live longer.<\/p>\n
RELATED:Roche's Tecentriq is the first I-O drug to claim a post-surgery win in lung cancer. But will doctors use it?<\/p>\n
Fuchs acknowledged the field is evolving but stressed that Tagrissos impressive showing was in a small subset of patients, whereas PD-L1-positive disease makes up 40% to 50% of all NSCLC cases. So he called Tecentriqs 34% improvement as clinically meaningful and practice-changing.<\/p>\n
The next question centers onTecentriqs benefit for PD-L1-negative patients. When those trial subjects were counted, Tecentriqs reduction of disease recurrence dropped to 21%, which is still statistically significant. Butthe rate fell below the statistical significance bar to 19% once all randomized patients, including those with stage IB disease, were included. <\/p>\n
Fuchs suggests that data from the stage IB patientswho made up 12% of the total trial populationare immature at the interim analysis because those patients are healthier;it takes longer for that group to accrue recurrence cases.<\/p>\n
RELATED:AstraZeneca's blockbuster Tagrisso gets major boost with FDA OK for early lung cancer use<\/p>\n
During Roches first-quarter earnings call a few weeks ago, Roches pharma chief Bill Anderson put the size of the market for resectable lung cancer at between $2 billion and $3 billion. But he also acknowledged the uncertainty of whether Tecentriq is for only PD-L1-positive patients or for all patients. He said he expectsmore mature disease-free survival data to answer that question.<\/p>\n
Roche isnow talking to the FDA and the European Medicines Agency to see what we collectively think is in the best interest of patients in terms of a potential label for Tecentriqs NSCLC adjuvant use, Fuchs said.<\/p>\n
As Roche awaits key life extension data from the IMpower010 trial, a recent survey by Jefferies analyst Peter Welford suggested that almost all physicians would rather wait until that data emerge to consider using a PD-1\/L1 therapy in that group.<\/p>\n
One reason for caution is the uncertainty of whether PD-1\/L1 inhibitors will work in metastatic cancer patients who were treatedwith one of the drugs early on. Its possible that physicians might reserve PD-1\/L1 for more advanced disease; Mercks PD-1 inhibitor Keytruda combined with chemo has become the standard of care for front-line treatment of metastatic disease because its proven to help patients live longer.<\/p>\n
The question of sequential PD-1\/L1 use needs to be addressed, Fuchs said, but he stressed the importance of advancing the landscape of cancer immunotherapy beyond the PD-1\/L1s.<\/p>\n
Meanwhile, other PD-1\/L1 players are also targeting adjuvant NSCLC. These include Ketyrudas Keynote-091 trial, which is expected to deliver data later this year.<\/p>\n
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ASCO: Roche's Tecentriq grabs I-O's first win in post-surgery lung cancer, but it's limitedand an FDA approval could be, too - FiercePharma<\/a><\/p>\n","protected":false},"excerpt":{"rendered":" In early cancer thats amenable to surgery, a field viewed as the next battleground for PD-1\/L1 immunotherapies, Roches Tecentriq has claimed the first post-operative win innon-small cell lung cancer. But the drugs role, at least in some patients, remains unclear. Continue reading