NEW YORK – Gilead Sciences reported after the close of market Thursday a 79 percent jump in oncology sales during the third quarter of 2022, driven by growing demand for its autologous CAR T-cell therapies and the antibody drug conjugate Trodelvy (sacituzumab govitecan).
During the three-month period ending Sept. 30, Gilead's oncology sales totaled $578 million. Q3 cell therapy revenue — comprising sales of Gilead subsidiary Kite Pharma's CD19-directed CAR T-cell therapies Yescarta (axicabtagene ciloleucel) and Tecartus (brexucabtagene autoleucel) — grew 79 percent to $398 million versus $222 million during the prior year's third quarter. Trodelvy sales climbed to $180 million in Q3 2022, up 78 percent from $101 million in Q3 2021.
Despite the soaring oncology growth, Gilead revenues on the whole declined 5 percent to $7.04 billion versus $7.42 billion in the prior year's third quarter. Gilead attributed this overall slight decline to lower sales of its COVID-19 drug Veklury (remdesivir).
Gilead posted net income of $1.79 billion, or $1.42 per share, compared to $2.59 billion, or $2.05 per share, for Q3 2021. On an adjusted basis, its EPS was $1.90 versus $2.65 in the comparable period of 2021. The lower profit was largely the result of higher costs associated with acquired in-process R&D expenses — $448 million in Q3 2022 compared to $65 million in Q3 2021.
As of the end of the quarter, the firm held $6.94 billion in cash, cash equivalents, and marketable securities.
In terms of its autologous cell therapies, Gilead highlighted a growing demand for both Yescarta and Tecartus as well as its improving capacity to meet that demand.
The largest growth driver for Yescarta — for which sales rose to $317 million this quarter, up 81 percent versus $175 million in Q3 2021 — was the shift into the earlier-stage lymphoma treatment setting. In April, the US Food and Drug Administration approved Yescarta as second-line treatment for patients with relapsed or refractory large B-cell lymphoma, moving it earlier from the later, third-line treatment setting. Just last week, the European Commission followed suit, approving Yescarta as the first second-line CAR T-cell therapy for LBCL patients in the EU.
Tecartus sales, meanwhile, rose 72 percent to $81 million during the third quarter 2022 versus $47 million in Q3 2021. The growth was mainly driven by demand among acute lymphoblastic lymphoma patients. In early September, the European Commission approved the CAR T-cell therapy for adult patients with relapsed or refractory B-cell precursor ALL, following the FDA's approval for this indication last year.
"We continue to broaden awareness and access to our cell therapy through … authorized treatment center expansion in existing markets as well as through geographic expansion," Gilead Chief Commercial Officer Johanna Mercier said during a conference call to discuss third quarter earnings on Thursday afternoon. Mercier mentioned that Gilead recently submitted regulatory applications for its cell therapies in Brazil, Singapore, and Saudi Arabia.
In the US, the firm recently broadened its CAR T-cell therapy manufacturing capabilities with a new viral vector manufacturing facility in Oceanside, California. "Kite remains well positioned to ensure clinical and commercial supply availability while it continues to execute on its geographic expansion," Mercier said.
According to Gilead Chief Medical Officer Merdad Parsey, Gilead is also actively working to expand Yescarta into new indications, even earlier treatment lines, and into easier-to-access outpatient treatment settings. Recently, Gilead began enrolling patients onto the Phase II ZUMA-24 study evaluating Yescarta in an outpatient setting for second-line LBCL as well as onto ZUMA-22, a Phase III study of Yescarta as second-line treatment for high-risk follicular lymphoma. During the fourth quarter of this year, Parsey said Gilead expects to begin screening patients for ZUMA-23, a study of the CAR T-cell therapy as a first-line treatment for high-risk LBCL patients.
Parsey said the decision to initiate a Phase III trial for the first-line cell therapy treatment setting was based on encouraging data from the Phase II ZUMA-12 trial, in which Yescarta demonstrated an 89 percent overall response rate and a 78 percent complete response rate.
As for Gilead's Trop2-directed antibody-drug conjugate Trodelvy, the 78 percent revenue increase was mainly driven by a growing demand among metastatic triple-negative breast cancer patients in both the second- and later-line treatment settings. Based on encouraging data from the TROPiCS-02 trial presented in June, Gilead is also gearing up for what it hopes will be a Trodelvy launch in previously treated hormone receptor-positive, HER2-negative breast cancer. In August, the firm submitted an application for this Trodelvy indication to the FDA and simultaneously announced it would acquire the remaining worldwide rights to Trodelvy from Everest Medicines, including rights in greater China, South Korea, Singapore, Indonesia, the Philippines, Vietnam, Thailand, Malaysia, and Mongolia.
"We've begun work establishing the right infrastructure to support a potential launch [in this HR-positive indication]," Mercier said, adding that the FDA has granted the application priority review and that she expects a decision in February 2023.
Looking ahead, Gilead is also working to expand its oncology portfolio into lung cancer, including with non-small cell lung cancer Trodelvy indications.
"We expect to have at least nine active clinical trials in non-small cell lung cancer by the end of 2022," said Parsey, adding that five of these trials involve Trodelvy, either alone and in combination with other agents, such as Merck's Keytruda (pembrolizumab). Later this year, Parsey said, Merck plans to launch the Phase III EVOKE-03 study to evaluate Trodelvy plus Keytruda as first-line treatment for non-small cell lung cancer patients whose tumors express high levels of PD-L1.
Beyond Yescarta, Tecartus, and Trodelvy, Gilead is also focusing its future oncology growth strategy on new agents, including magrolimab, an investigational drug it's evaluating for TP53-mutant acute myeloid leukemia, among other hematologic malignancies. The firm hopes to report top-line data for magrolimab in AML during 2024.
Gilead is also fresh off a recently announced collaboration with MacroGenics to develop bispecific antibodies, including MGD024, for hematologic malignancies including AML and myelodysplastic syndrome. Meanwhile, the FDA recently granted orphan drug designation to a new CAR T-cell therapy, KITE-222, which is designed to target CLL-1 on the surface of AML cells. Gilead is currently evaluating that new therapy in a Phase I clinical trial for relapsed or refractory AML.