NEW YORK – Roche reported before markets opened on Wednesday a 5 percent increase in pharmaceutical revenues in the third quarter of 2021, with precision oncology breast cancer drug pertuzumab (Perjeta) and immunotherapy atezolizumab (Tecentriq) contributing to the growth.
The Roche Group reported CHF 15.97 billion ($17.31 billion) in total sales during the three months ended Sept. 30, up 8 percent from CHF 14.70 billion in Q3 2020.
Revenues for the pharmaceutical division came in at CHF 11.71 billion, up 5 percent compared to CHF 11.12 billion during Q3 2020. Compared to the year-ago quarter, drug sales in the US were essentially flat at CHF 5.91 billion; up 1 percent in Europe to CHF 2.13 billion; up 60 percent in Japan to CHF 1.38 billion; and up 2 percent in other international markets to CHF 2.30 billion.
The company's Diagnostics division sales in Q3 2021 were CHF 4.26 billion, up 18 percent compared to CHF 3.58 billion in Q3 2020.
Although pharmaceutical sales declined by 3 percent (or were flat at constant exchange rates) over the nine months of 2021 to CHF 33.38 billion from CHF 34.32 billion during the year-ago period, Roche CEO Severin Schwan said during a call to discuss the company's financial results that Roche's core businesses are continuing to recover from the negative impact of the COVID-19 pandemic.
"Newly launched products both in pharma and in diagnostics are actually developing very well," Schwan said. During Q3, continued demand for COVID-19 testing bolstered diagnostics revenues, while pharmaceutical sales benefited from newly launched medicines and strong sales of oncology drugs, such as atezolizumab, pertuzumab and the injectable fixed-dose pertuzumab/trastuzumab/hyaluronidase regimen (Phesgo).
The HER2-targeted breast cancer drug pertuzumab, which became Roche's top-selling oncology drug last quarter, contributed CHF 1.01 billion in Q3 2021, a 2 percent increase from CHF 988 million in Q3 2021. Other drugs in Roche's HER2 targeted therapy franchise include the HER2 antibody drug conjugate ado-trastuzumab emtansine (Kadcyla), and the older trastuzumab (Herceptin). Ado-trastuzumab emtansine had Q3 2021 sales of CHF 501 million, an 11 percent increase from CHF 458 million in the prior year's quarter. Trastuzumab sales were CHF 665 million, down 26 percent from CHF 879 million in Q3 2020, largely due to biosimilar competition.
Roche's PD-L1 inhibitor atezolizumab netted revenues of CHF 878 million in Q3 2021, a 23 percent increase in sales from CHF 718 million in Q3 2020, driven by continued global penetration in lung cancer indications and in liver cancer. Alectinib (Alecensa), a treatment for ALK-positive non-small cell lung cancer, brought in revenues of CHF 357 million during the quarter, an 18 percent increase from CHF 301 million in the prior-year period.
Based on the company's performance across its business units, Roche increased its full-year guidance. The company is now expecting 2021 revenues to grow in the mid-single digit range at constant exchange rates compared to its previous expected growth in the low- to mid-single digit range.
In terms of its R&D pipeline, Bill Anderson, CEO of Roche Pharmaceuticals, highlighted the positive data readout for the investigational oral SERD giredestrant as a neoadjuvant treatment for post-menopausal women with estrogen receptor-positive, HER2-negative early breast cancer. At the European Society for Medical Oncology Congress in September, the company reported that after 14 days of treatment, giredestrant reduced Ki67, a prognostic tumor proliferation marker, in 80 percent of patients in the CoopERA trial compared to Ki67 reductions in 67 percent of patients on anastrozole.
"This is our first attempt to really displace the aromatase inhibitors that are typically used in the first line and in multiple lines in the hormone receptor-positive breast cancer setting," Anderson said. Roche is also studying this drug in the adjuvant setting, slated to readout in a few years, and in the second- and third-line metastatic breast cancer setting, which will readout next year.
Additionally, Anderson highlighted that the US Food and Drug Administration last week approved atezolizumab as an adjuvant treatment after resection and platinum-based chemotherapy for non-small cell lung cancer patients whose tumors express PD-L1 in at least 1 percent of cells. Ahead of this approval, there was significant discussion among leading oncologists over the most appropriate PD-L1 expression cutoff for identifying best responders, because in the IMpower010 trial those with PD-L1 expression in more than 50 percent of tumor cells derived a far greater magnitude of benefit from adjuvant atezolizumab than those with PD-L1 expression in 1 percent to 49 percent of tumor cells.
Anderson suggested that the opportunity to prevent lung cancer recurrence in the early disease setting is an attractive enough proposition that there will be uptake of atezolizumab across low-to-high PD-L1 expression groups. "It may be faster to penetrate in the highest category of PD-L1 positivity versus patients with lower levels of PD-L1," he said. Generally, Roche is expecting "good uptake" of atezolizumab in this setting, though it "probably won't happen all in one day," he added.
In terms of new cancer tests, Thomas Schinecker, CEO of Roche Diagnostics, said the company is working on a decentralized kit version of subsidiary Foundation Medicine's FoundationOne next-generation sequencing panel, which is currently available as a lab-developed test for guiding therapy decisions for cancer patients.