EC Approves Label Expansion of GILD's Trodelvy in First-line Metastatic TNBC

Gilead Sciences, Inc.  GILD recently announced that the European Commission (EC) has approved label expansion of the breast cancer drug Trodelvy (sacituzumab govitecan-hziy).

The EC granted marketing authorization to Trodelvy in combination with Merck’s MRK Keytruda (pembrolizumab) for the treatment of adult patients with unresectable, locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic disease and whose tumors express PD-L1 with a combined positive score (CPS ≥10).

Trodelvy, a first-in-class Trop-2-directed antibody-drug conjugate (ADC), is already approved in several countries for second-line or later metastatic TNBC and in more than 50 countries for certain patients with pre-treated HR+/HER2- metastatic breast cancer (mBC).

Per GILD, Trodelvy plus Keytruda is the first and only ADC plus immunotherapy combination to be approved in first-line metastatic TNBC in the European Union’s 27 member states, as well as Norway, Iceland and Liechtenstein.

Shares of GILD have gained 20.4% year to date compared with the industry’s growth of 10.7%.

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More on EC’s Latest Label Expansion of GILD’s Trodelvy

The latest EC approval is based on positive results from the late-stage ASCENT-04/KEYNOTE-D19 study, which showed a statistically significant and clinically meaningful improvement in progression-free survival with Trodelvy plus Keytruda compared with standard-of-care chemotherapy plus Keytruda as a first-line treatment. In the study, Trodelvy reduced the risk of disease progression or death by 35% in patients with PD-L1-positive metastatic TNBC.

The latest decision follows the EC’s recent approval of Trodelvy as a monotherapy for adults with unresectable, locally advanced or metastatic TNBC who have not received prior systemic therapy for metastatic disease and are not eligible for PD-1 or PD-L1 inhibitor treatment.

Together, the approvals position Trodelvy as a potential backbone therapy for first-line metastatic TNBC in Europe, regardless of PD-L1 status. The expanded indication offers a new treatment option for patients with this aggressive form of breast cancer at the onset of metastatic disease.

Trodelvy is also approved in first-line mTNBC in the United States, either as a single agent for patients who are not candidates for PD-(L)1 inhibitor-based therapy or in combination with Keytruda (pembrolizumab) or Keytruda Qlex (subcutaneous injection of Keytruda) for patients whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-authorized test.

The drug is currently being evaluated in multiple ongoing late-stage studies across a range of tumor types with high Trop-2 expression, including lung and gynecologic cancers, where previous proof-of-concept studies have demonstrated clinical activity.

Merck and Gilead Sciences had earlier announced discontinuation of the phase III KEYNOTE-D46/EVOKE-03 study evaluating Trodelvy in combination with Keytruda as a first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express high levels of PD-L1 (TPS ≥50%).

GILD’s Efforts to Diversify Revenue Base

The recent label expansions are expected to strengthen Trodelvy's commercial opportunity and reinforce its position as a key growth driver within Gilead's oncology portfolio.

Trodelvy sales increased 26% year over year to $457 million in the second quarter, driven by stronger demand across triple-negative and previously treated HR-positive/HER2-negative metastatic breast cancer.

GILD is looking to strengthen its oncology franchise and diversify its revenue base, which is highly concentrated on HIV business.

Gilead’s recent aggressive dealmaking strategy, including the acquisitions of Arcellx and Tubulis, underscores its commitment to diversifying beyond its core HIV franchise and expanding into higher-growth oncology and immunology markets.

Gilead recently delivered a strong second quarter, with both earnings and revenues exceeding expectations. The HIV franchise remains the principal growth engine, supported by Biktarvy's durability and rapid expansion of the prevention business.
Descovy and Yeztugo’s strong performance is boosting the top-line growth. Per GILD, Yeztugo has quickly become the leading long-acting PrEP option for new patient starts.

Approval of additional better treatments should bolster GILD’s HIV franchise in the wake of increasing competition from the likes of GSK plc GSK.

HIV sales account for a major chunk of GSK’s Specialty Medicines portfolio. GSK continues to grow its HIV business, driven by strong patient demand for long-acting injectable medicines (Cabenuva and Apretude) and Dovato. The solid growth from these drugs has helped GSK combat the decline in Triumeq sales.

GILD’s Zacks Rank

Gilead currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

 

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