NEW YORK – After the close of market on Tuesday, Gilead Sciences said that sales of its oncology products soared during the second quarter of 2022, growing 71 percent from Q2 2021, driven largely by uptake of Trodelvy (sacituzumab govitecan) and its autologous CAR T-cell therapies Yescarta (axicabtagene ciloleucel) and Tecartus (brexucabtagene autoleucel).
For the three months ending June 30, Foster City, California-based Gilead Sciences brought in $527 million in oncology sales. The growth was enough to offset significant revenue losses for the firm's COVID-19 treatment Veklury (remdesivir) and hepatitis C drugs. Overall, Gilead brought in $6.26 billion in revenue during the second quarter of this year, up 1 percent from $6.22 billion during Q2 2021.
Sales of Trodelvy, the firm's Trop-2-directed antibody-drug conjugate for previously treated metastatic triple-negative breast cancer and metastatic urothelial cancer, increased 79 percent to $159 million in Q2 2022 from $89 million during the year-ago period.
The strong revenue growth for the drug in Q2 continued from Q1, during which Trodelvy revenues nearly doubled compared to the same period in the prior year. The drug originally belonged to Immunomedics, which Gilead acquired in 2020.
"We're committed to broadening access for Trodelvy and continue to work with regulators and payors around the world," Gilead Chief Commercial Officer Johanna Mercier said on a conference call to discuss Gilead's second-quarter earnings on Tuesday. According to Mercier, the firm expects sales of the drug to continue growing as uptake and approvals spread to more regions of the world.
According to Gilead, the growth was a reflection of strong European sales in second-line and later metastatic TNBC as well as the fact that, in the US, the National Comprehensive Cancer Network has included the treatment as a category 1 "preferred regimen" in its metastatic TNBC treatment guidelines.
Recently, the National Institute for Health and Care Excellence (NICE) in England reached a pricing agreement with Gilead making Trodelvy available as a third-line treatment for advanced TNBC patients there.
Although Trodelvy is not currently approved for hormone-positive, HER2-negative metastatic breast cancer, data from the Phase III TROPiCS-02 trial presented during the recent American Society of Clinical Oncology annual meeting have the firm eager to expand the indication into the hormone receptor-positive patient population.
Based on the positive progression-free survival data from the TROPiCS-02 interim analysis, NCCN has included Trodelvy as a category 2a recommendation for the hormone receptor-positive advanced breast cancer group ahead of regulatory approval in this setting.
"The TROPiCS-02 data coupled with the NCCN recommendations support Trodelvy's potential as a treatment option for late-line, HR-positive, HER2-negative patients," Gilead's Chief Medical Officer Merdad Parsey said, noting that the drug also demonstrated a positive trend in overall survival in this patient population during an interim analysis of the TROPiCS-02 data.
"Our discussions with the FDA are ongoing for the potential regulatory path," Parsey said, noting that the company hopes to provide a regulatory update in the second half of the year and potentially submit a supplemental biologics application in the second half of the year.
Beyond TROPiCS-02, Parsey shared that Gilead is continuing to expand its Trodelvy clinical program, including through the ASCENT-03 clinical trial evaluating the drug as a first-line treatment for PD-L1-negative metastatic TNBC patients and in the ASCENT-04 clinical trial for PD-L1-positive metastatic TNBC patients.
Gilead also recently launched the Phase II EVOKE-02 trial evaluating Trodelvy in combination with Merck's Keytruda (pembrolizumab) in patients with non-small cell lung cancer whose tumors lack actionable mutations. During the second half of this year, Gilead and Merck plan to launch a Phase III trial dubbed EVOKE-03 evaluating Trodelvy and Keytruda as a first-line treatment for NSCLC patients whose tumors express PD-L1 in over 50 percent of cells.
Cell therapy momentum
The autologous CAR T-cell therapies Yescarta and Tecartus — products of Gilead subsidiary Kite Pharma — saw significant growth this quarter, too. In Q2 of this year, the two cell therapies brought in $368 million, up 68 percent from $219 million during the year-ago quarter.
Yescarta sales were $295 million during Q2 2022, up 66 percent from $178 during Q2 2021. Gilead credited much of the surge to Yescarta's growing demand across expanded patient populations in both the US and Europe. In April, the US Food and Drug Administration approved the therapy as a second-line treatment for large B-cell lymphoma. The treatment had previously been an option for relapsed or refractory LBCL patients after two or more prior therapies, so the earlier-line approval increased the eligible population significantly.
In June, the European Commission approved Yescarta as a fourth-line treatment for relapsed or refractory follicular lymphoma patients.
Looking ahead, Parsey shared that Gilead expects to begin enrolling patients to the Phase II ZUMA-24 trial evaluating Yescarta as an outpatient treatment in second-line LBCL in the second half of this year. The firm also aims to begin ZUMA-23, a Phase III study evaluating the treatment in the first-line setting for LBCL patients whose disease is deemed high-risk. Finally, Parsey said Gilead plans to start a new Phase III trial, ZUMA-22, for Yescarta as a second-line treatment for high-risk follicular lymphoma patients during the second half of 2022.
Meanwhile, Tecartus, the firm's autologous CD19-directed CAR T-cell therapy for mantle cell lymphoma and B-cell precursor acute lymphoblastic leukemia, brought in $73 million during Q2 2022, up 78 percent from $41 million during Q2 2021. According to Gilead, the growth has been driven by demand in new geographic regions, which could increase further following a recent positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) to approve the treatment for ALL in Europe.
Beyond Trodelvy and the cell therapies, Gilead has an investigational agent in its pipeline dubbed magrolimab that it is evaluating for various hematologic malignancies including TP53-mutant acute myeloid leukemia. Early this year, the FDA placed a partial clinical hold on clinical trials of the drug, citing concerns about serious adverse events. However, in April, the agency lifted the hold, and according to Parsey, "all magrolimab programs have resumed enrolling patients without FDA requiring any additional protocol changes."
So far, early data have shown encouraging signals for the anti-CD47 antibody in high-risk myelodysplastic syndrome and in TP53-mutant AML.