Skip to main content
Premium Trial:

Request an Annual Quote

Roche Eyes Breast Cancer Drug Growth in 2024 With New Products, Expanded Indications


NEW YORK – Roche aims to expand its precision breast cancer assets in 2024 and beyond with anticipated regulatory filings for its PI3Kα inhibitor inavolisib in the US and Europe and additional trial readouts for other breast cancer products.

In December, Roche reported results from the Phase III INAVO120 trial at the San Antonio Breast Cancer Symposium showing that inavolisib, which was developed by Roche subsidiary Genentech, combined with Pfizer's CDK 4/6 inhibitor Ibrance (palbociclib) and selective estrogen degrader fulvestrant reduced the risk of disease progression by 57 percent in patients with hormone receptor-positive, HER2-negative advanced breast cancer compared to Ibrance and fulvestrant alone, with a consistent benefit across subgroups. Median progression-free survival for patients in the inavolisib group was 15.0 months compared to 7.3 months for patients on Ibrance and fulvestrant. The investigators noted a trend toward an overall survival benefit, though the data were immature at the time of the readout.

"We're very much looking forward to continuing our conversations with health authorities and looking forward to approval of this drug, hopefully this year," Roche Pharmaceuticals CEO Teresa Graham said in a call Thursday morning to discuss the company's financial results.

Inavolisib is a potential competitor for Novartis' PI3Kα inhibitor Piqray (alpelisib) in patients with PIK3CA-mutated breast cancer. Piqray is currently the only drug approved for this patient population, which represents about 40 percent of hormone receptor-positive breast cancer cases, and inavolisib is Piqray's closest-to-market competitor. Roche is conducting a head-to-head trial (INAVO121) of inavolisib versus Piqray that could give inavolisib an edge in terms of efficacy and safety, especially if it has lower rates of hyperglycemia, a common side effect that bedevils PI3Kα inhibitors. The company is also studying inavolisib in the Phase II INAVO122 trial combination with its HER2-targeted combination subcutaneous injection Phesgo (pertuzumab/trastuzumab/hyaluronidase) in patients with HER2-positive, HR-positive, PIK3CA-mutant breast cancer.

At the same time, Roche is working to solidify Kadcyla (trastuzumab emtansine) as the standard of care in HER2-positive early-stage breast cancer with residual invasive disease. Graham highlighted data from the Phase III KATHERINE trial, also presented at SABCS in December, showing an absolute overall survival benefit of 4.7 percent at seven years for early-stage HER2-positive breast cancer patients on Kadcyla versus Genentech's Herceptin (trastuzumab). Graham said the company is additionally making a "significant investment" in HR-positive breast cancer with multiple clinical trials of its estrogen receptor antagonist giredestrant.

Roche's revenue for the fourth quarter in 2023 was unchanged at constant exchange rates (CER) at CHF 14.66 billion ($15.72 billion) compared to CHF 16.24 billion in the same quarter in 2022. Revenues from the Swiss drugmaker's pharmaceuticals division fell 2 percent to CHF 10.99 billion compared to CHF 12.36 billion during the same period in 2022. Roche Group CEO Thomas Schinecker said in the call that the company faced significant headwinds from declining sales of COVID-19 products and biosimilars, amounting to about CHF 6.4 billion, or more than 10 percent of sales. He also noted that appreciation of the Swiss franc versus most currencies has impacted financial results reported in Swiss francs.

Sales of Tecentriq (atezolizumab), a PD-L1 inhibitor developed by Genentech, contributed CHF 975 million to Q4 2023 revenues, a 5 percent increase at CER compared to CHF 1.03 billion in Q4 2022. Sales were driven primarily by hepatocellular carcinoma in Europe and outside the US and by adjuvant non-small cell lung cancer. Roche recently garnered approval in Europe for its subcutaneous formulation of Tecentriq and is anticipating US Food and Drug Administration approval in September.

In Roche's HER2 franchise, Perjeta (pertuzumab) sales were CHF 773 million, a decrease of 11 percent from CHF 997 million at CER in Q4 2022. Graham said Perjeta Q4 sales were negatively impacted by a one-time adjustment in reserves related to US government programs, and excluding that impact, Perjeta sales growth was around 1 percent. Sales of Phesgo were CHF 303 million, a 73 percent increase from CHF 214 million in the same period in 2022.

Kadcyla sales during the same period were CHF 480 million, a 2 percent decline at CER from CHF 490 million. Graham noted that Kadcyla sales were primarily driven outside the US by early breast cancer, offsetting declines in the EU and US due to competition in the metastatic setting.

Sales of Alecensa (alectinib), a treatment for ALK-positive metastatic NSCLC, contributed CHF 376 million in Q4 2023, a 3 percent decline from CHF 386 million at CER in Q4 2022. The FDA recently accepted a supplemental new drug application from Roche seeking approval of Alecensa as an adjuvant therapy for early-stage ALK-positive NSCLC based on results from the Phase III ALINA trial and granted priority review. A decision on that application is expected by May 22.

"The strong Phase III ALINA data submitted to the FDA provides evidence that [Alecensa] could also play a pivotal role in early-stage disease, where there is significant unmet need," Josina Reddy, Genentech's VP and global head of development for lung cancer wrote in an email. "If approved in this setting, Alecensa has the potential to treat cancer before it has spread, altering the course of this disease as we aim to provide the best chance for a cure."

In rare diseases, Roche and partner Sarepta Therapeutics will treat the first patient in Q1 with the newly approved gene therapy for Duchenne muscular dystrophy, Elevidys (delandistrogene moxeparvovec). Although the Phase III EMBARK trial of the product in DMD patients ages 4 through 7 did not meet its primary endpoint, Graham said, "when you actually see the data … you can see that there really is a benefit to these boys."

In part 1 of the trial, 125 patients were randomized to receive Elevidys or placebo and were followed for 52 weeks. In part 2, the participants crossed over to the opposite arm and were followed for another 52 weeks. The primary endpoint of the trial is change from baseline in North Star Ambulatory Assessment total score at week 52. The difference between the treatment group and placebo group for that endpoint did not reach statistical significance. However, Graham noted that the secondary endpoints, time to rise and 10-meter walk test, represent "clinically meaningful results."

"We are very eager to bring this data to the [European Medicines Agency] and other global regulators," Graham said.

For the full year in 2023, Roche reported total revenues of CHF 58.72 billion, a 7 percent decline from CHF 63.28 billion in 2022, though the firm pointed out sales were up 1 percent at CER. Product sales for the pharmaceutical division over the same period dropped 2 percent to CHF 44.61 billion from CHF 45.55 billion, but were up 6 percent at CER, while revenues for the diagnostics division fell 20 percent, and 13 percent at CER, to CHF 14.10 billion.

In 2023, Tecentriq sales increased 9 percent to CHF 3.77 billion, Perjeta sales grew 1 percent to CHF 3.77 billion, and Kadcyla sales increased 4 percent to CHF 1.97 billion. Sales of Phesgo increased 64 percent during the year to CHF 1.12 billion.

As of Dec. 31, Roche had CHF 5.38 billion in cash and cash equivalents and CHF 5.13 billion in marketable securities. In 2024, Roche is expecting group sales in the mid-single-digit range at CER.