NEW YORK – Sales of Gilead Sciences' TROP2-directed antibody-drug conjugate Trodelvy (sacituzumab govitecan) soared once again during the third quarter of 2023, climbing 57 percent compared to Q3 2022, the firm reported after the close of market on Tuesday.
Trodelvy contributed positively to Gilead's oncology drug segment, which contributed $769 million to Q3 2023 revenues, up 33 percent from $578 million in Q3 2022. For the three months ending Sept. 30, the Foster City, California-based firm reported total revenues of $7.05 billion, essentially flat compared to $7.04 billion in the year-ago quarter and exceeding analysts' average revenue expectation of $6.42 billion. Gilead attributed the flat performance to lower sales of its COVID-19 treatment Veklury (remdesivir). Excluding Veklury, Gilead product sales increased 5 percent year over year in Q3 2023.
Sales of Trodelvy, which Gilead markets for certain advanced breast and bladder cancer patients, increased to $283 million from $180 million in Q3 2022. In late July, the drugmaker netted European approval for Trodelvy in hormone receptor-positive, HER2-negative metastatic breast cancer. In September, Gilead shared data from its ongoing EVOKE-02 clinical trial, showing that Trodelvy plus Merck's checkpoint inhibitor Keytruda (pembrolizumab) benefited patients with advanced non-small cell lung cancer.
During a call to discuss Gilead's Q3 financials on Tuesday afternoon, Gilead Chief Medical Officer Merdad Parsey referred to the data readout as the "clinical highlight of the third quarter."
Among NSCLC patients with tumors expressing PD-L1 in at least 50 percent of cells, the overall response rate was 69 percent if they received Trodelvy-Keytruda in the first-line setting. Among patients with lower PD-L1 expression, the overall response rate was 44 percent on the combination.
"These results inform our plans to expand into broader first-line NSCLC patient populations across all PD-L1 expression levels," Parsey said. "We're looking forward to sharing further analyses from EVOKE-02 that will highlight the efficacy of Trodelvy and pembrolizumab across both squamous and non-squamous histologies in first-line metastatic NSCLC patients."
Gilead also reported 22 percent revenue growth in its cell therapy business, Kite, during Q3 2023. The firm's two cell therapy products brought in $486 million during the quarter, up from $398 million in Q3 2022. The CD19-directed autologous CAR T-cell therapy Yescarta (axicabtagene ciloleucel) recorded $391 million in Q3 2023, up 23 percent from $317 million in Q3 2022. Sales of the firm's other CAR T-cell therapy, Tecartus (brexucabtagene autoleucel), climbed 19 percent to $96 million from $81 million a year ago.
On Monday, the day before Gilead reported its Q3 earnings, the firm unveiled data from the Phase II EDGE-Gastric study, assessing its anti-TIGIT agent, domvanalimab, which the firm is developing in collaboration with Arcus Biosciences in advanced gastric cancers. In the EDGE-Gastric study, domvanalimab combined with Arcus' PD-L1 agent zimberelimab plus chemotherapy led to a 77 percent six-month progression-free survival rate and 59 percent overall response rate in first-line metastatic upper gastrointestinal cancers. In patients with PD-L1-high tumors, defined as tumors expressing PD-L1 with a tumor area positivity of at least 5 percent, the overall response rate to the combination was 80 percent and the six-month progression-free survival rate was 93 percent.
"These results increase our confidence in the ongoing registrational Phase III STAR-221 trial in a similar first-line gastric, gastroesophageal junction, and esophageal adenocarcinoma population, and our broader anti-TIGIT program," Parsey said. "Although anti-TIGIT will not work in every tumor type, we're excited to see that domvanalimab has shown encouraging efficacy and tolerability in the tumor types we have advanced into Phase III studies." The treatment combination has also shown potential in PD-L1-high NSCLC, according to Phase II data from the ARC-7 study.
Gilead posted net income of $2.18 billion, or $1.73 per share, in Q3 2023, compared to $1.79 billion, or $1.42 per share, in Q3 2022. Non-GAAP diluted EPS was $2.29, above the $1.81 per share that analysts had estimated on average.
As of Sept. 30, Gilead had $8.02 billion in cash, cash equivalents, and marketable debt securities.
Looking ahead, Gilead adjusted its total product sales estimate for the full year to be in the range of $26.7 billion to $26.9 billion. Previously, the firm was anticipating product sales between $26.3 billion and $26.7 billion. Gilead is now expecting diluted EPS in the range of $4.55 to $4.75 compared to prior guidance of $4.50 to $4.85. It is also expecting non-GAAP EPS of between $6.65 and $6.85 compared to prior guidance of $6.45 to $6.80.