Following the standing ovation for Seagen and Astellas’ Padcev in combination with Merck’s Keytruda at last year’s ESMO Congress, Merck KGaA is seeing US sales erode for its urothelial carcinoma drug Bavencio in the second quarter.
Bavencio’s overall Q2 sales increased 6.4% from the same period last year to reach €186 million ($200.6 million), according to a Thursday release. While Merck KGaA did not detail drug sales by geography, CEO Belén Garijo said during its media call that there was a drop in sales in the US because of growing competition, adding this is “in absolute alignment with our expectations.”
In a Thursday note, Jefferies analysts spelled out that Bavencio sales missed analyst consensus estimates by five percentage points, likely due to competition in the US from Padcev/Keytruda. For context, Padcev sales from April through June grew 152% to 38.4 billion yen ($255.9 million).
In October last year, Phase 3 results for Nectin-4 targeting antibody-drug conjugate Padcev plus Keytruda in first-line bladder cancer were met with a standing ovation at ESMO as it was heralded as a new standard of care. Padcev/Keytruda had its accelerated approval converted to full approval by the FDA in December.
Bavencio, an anti-PD-L1 antibody, won US accelerated approval for previously treated locally advanced or metastatic urothelial carcinoma in 2017, followed by a label expansion to the first-line setting in 2020.
Padcev/Keytruda achieved a median overall survival of 31.5 months in its Phase 3 trial. Although it’s difficult to compare results across separate studies, this appears better than the 29.7-month OS attained by Bavencio plus standard chemotherapy from the start of first-line chemotherapy in its registrational JAVELIN Bladder 100 trial.
As for Merck KGaA’s broader oncology franchise, Q2 sales were up 9.2% to €490 million ($528 million), supported by the growth of head and neck cancer drug Erbitux. The German drugmaker’s oncology pipeline had a setback last month when its drug candidate for squamous cell carcinoma of the head and neck, xevinapant, was deemed unlikely to hit a primary endpoint in one of two Phase 3 studies, prompting the company to wind down both trials.