The design of KEYNOTE-355 is similar to that of Roche’s IMpassion130 study of Tecentriq plus chemo in TNBC, so the two drugs will compete toe-to-toe if Keytruda gets approval – assuming the results are similar. The positive top-line results are a relief to Merck, which suffered a setback in its TNBC programme last year when Keytruda failed to show an improvement over chemotherapy in patient survival when given as a monotherapy in the phase 3 KEYNOTE-119 trial.
The actual progression-free survival (PFS) numbers for KEYNOTE-355 – which compared Keytruda plus Bristol-Myers Squibb/Celgene’s Abraxane (nab-paclitaxel), paclitaxel or gemcitabine/carboplatin to the chemo drugs given alone – aren’t being revealed yet but will be presented at a future medical conference and shared with regulators. Patients who are PD-L1 positive represent a subgroup of about 40% of this total. TNBC is an aggressive and hard-to-treat subtype of breast cancer, representing around 15% of all breast cancer worldwide, approximately 300,000 cases every year. Roche’s drug was approved in the US and Europe for use in adults with PD-L1-positive unresectable, locally advanced or metastatic TNBC last year, and the company estimates the indication could be worth up to $1bn in additional revenues for the drug. Keytruda is the top-selling PD-1/PD-L1 inhibitor worldwide thanks to its dominance in lung cancer, but in TNBC it is playing catch-up with Roche’s Tecentriq (atezolizumab).
KEYNOTE 355 TRIAL
Merck & Co/MSD has chalked up a clinical trial win for its PD-1 inhibitor Keytruda in triple-negative breast cancer that it says may form the basis of regulatory filings.Īn interim analysis of the KEYNOTE-355 trial showed that adding Keytruda (pembrolizumab) to chemotherapy in previously-untreated TNBC patients whose tumours test positive for the PD-L1 biomarker extended the time to disease progression or death compared to chemo plus placebo.
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