NEW YORK – Roche reported "standout" sales growth for the HER2-targeted drug Phesgo (pertuzumab/trastuzumab/hyaluronidase) in the first half of 2023, as conversion rates from intravenous Herceptin (trastuzumab) and Perjeta (pertuzumab) to the subcutaneous injection climbed to 35 percent in early-launch countries.
Sales of Phesgo, a fixed-dose subcutaneous formulation of Herceptin and Perjeta marketed for HER2-positive breast cancer, grew 69 percent in the first half of 2023 to CHF 517 million ($596.13 million) compared to H1 2022. The drug's sales growth marked a bright spot in Roche's pharmaceutical division, which recorded CHF 22.68 billion in revenues in the first half of 2022, up 1 percent in Swiss francs or 8 percent at constant exchange rates (CER) compared to CHF 22.35 billion the first half of 2022. Revenues from Roche's overall oncology portfolio, including the PD-L1 inhibitor Tecentriq (atezolizumab), the ALK inhibitor Alecensa (alectinib), and products in the company's HER2 and hematology franchises, grew 4 percent at CER in H1 2023 compared to the year-ago period.
Roche's group sales, comprising revenues from its drug and diagnostics divisions, for the six months ended June 30 fell 8 percent in Swiss francs or 2 percent at CER to CHF 29.78 billion from CHF 32.30 billion for the first half of 2022 due to expected declines in COVID-19 sales, Roche Group CEO Thomas Schinecker said in a conference call to discuss the company's half-year financials. Revenues from Roche's diagnostics division fell 23 percent at CER to CHF 7.10 billion from CHF 9.95 billion in the year-ago period.
In discussing the increasing uptake of Phesgo, Roche Pharmaceuticals CEO Teresa Graham said the conversion rate for the drug has been as high as 92 percent in Great Britain and is expected to increase even more in the future, "which shows that when you actually have a dosing formulation that increases convenience and administration in this way, you could see very significant uptake." In step with growing conversions to Phesgo, Roche is also seeing increased sales of intravenous Perjeta, which is indicated for use with Herceptin and docetaxel for treating HER2-positive breast cancer. "We expect to see continued strong growth for Phesgo, and therefore, Perjeta," said Graham.
Phesgo was approved in June 2020 by the US Food and Drug Administration as a more convenient alternative for patients prescribed dual HER2 therapy who had to receive separate intravenous Perjeta and Herceptin infusions. In the Phase III FeDeriCa trial of 500 patients with early HER2-positive breast cancer in the neoadjuvant setting, Phesgo was non-inferior to IV Perjeta and Herceptin by serum concentrations and had comparable pathologic complete response rates and safety profiles. In another clinical trial, the Phase II PHranceSCa study, investigators evaluated patients' preferences after experiencing both subcutaneous therapy with Phesgo and intravenous Perjeta and Herceptin infusions and found that 85 percent of patients strongly preferred Phesgo.
Roche hopes to see similar strong conversions for its subcutaneous formulation of the immunotherapy Tecentriq, which is approved in a variety of indications including for treating non-small cell lung cancer in the adjuvant and first-line metastatic setting for patients with PD-L1-expressing tumors.
In August 2022, Roche reported results from the Phase III IMscin001 trial, which showed that a subcutaneous formulation of Tecentriq was non-inferior to intravenous Tecentriq in patients with advanced non-small cell lung cancer. "Tecentriq is the first PD-L1 [inhibitor] with pivotal [subcutaneous] trial results, which have now been filed in both the US and EU," Graham said. Roche expects the FDA to decide whether to approve the new formulation by Sept. 15.
Tecentriq contributed CHF 1.85 million to Roche's H1 2023 revenues, a 12 percent increase at CER compared to H1 2022.
In Roche's HER2 franchise, Perjeta sales were CHF $2.08 billion, a 9 percent increase at CER from H1 2022. Sales of Kadcyla (trastuzumab emtansine) in the first half of the year were flat at CHF 1.00 billion. Although Kadcyla has lost market share in the metastatic setting in the US and Europe, Graham said growth in sales of the HER2-targeted antibody-drug conjugate in the early breast cancer setting is compensating for the losses.
Sales of Alecensa, a treatment for ALK-positive metastatic NSCLC, contributed CHF 758 million in H1 2023, a 10 percent increase at CER from H1 2022.
Due to continuing declines in sales of COVID-19 products of about CHF 5 billion in the second half of 2023, Roche is expecting a decrease in overall annual sales in the low-single-digit range at CER. Excluding that impact, it is anticipating "solid sales growth" in both the pharmaceutical and diagnostic divisions.