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Gilead's Landmark Progress in Treating TNBC

Gilead Sciences, headquartered in Foster City, California, has announced a significant step forward in the treatment of triple-negative breast cancer (TNBC), a particularly aggressive and challenging cancer form. On July 24, 2023, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the approval of the combination therapy of sacituzumab govitecan and pembrolizumab (marketed as Keytruda) for adults suffering from PD-L1 positive, locally advanced, or metastatic TNBC without previous systemic therapy.

The Significance of this Approval

If the European Commission (EC) finalizes this approval, expected by late 2026, it will represent a second indication for sacituzumab govitecan in first-line treatment, establishing it as a cornerstone in the treatment landscape for TNBC, independent of PD-L1 expression status. TNBC is known for its rapid progression and poor prognosis, with approximately 40% of patients being PD-L1 positive, correlating with a more aggressive disease and shorter survival times. Therefore, timely access to effective treatment is crucial.

Insights from Clinical Trials

The positive opinion from CHMP is grounded on data from the Phase III clinical trials, ASCENT-04 and KEYNOTE-D19, which demonstrated that the combination therapy significantly reduced the risk of disease progression or death by 35% compared to standard chemotherapy plus Keytruda. These trials emphasize the necessity for early treatment options for TNBC patients, particularly those who are PD-L1 positive.

Dr. Evandro de Azambuja, the investigator for the ASCENT-04 trial and head of the Jules Bordet Institute, stated, “Patients with TNBC need effective treatment options as early as possible, especially those who are PD-L1 positive. This positive opinion is welcome news for patients and the entire medical community.”

Expanding Treatment Options

The recommendation from CHMP sets the stage for the combination of sacituzumab govitecan and pembrolizumab to follow the already approved monotherapy. According to Dr. Mika Kakefuda Derynck, Senior Vice President at Gilead's oncology clinical development department, “This opinion builds on our established leadership in the TNBC space and strengthens our commitment to the breast cancer community.” He emphasizes the urgency of providing new treatment options for TNBC patients.

Double-Edged Sword of TNBC

Triple-negative breast cancer represents about 15% of all breast cancer cases and is categorized as high-grade malignancy. Often diagnosed in younger, premenopausal women, TNBC shows a higher incidence in Black and Hispanic women. These tumors lack hormone receptors and present limitations in treatment options, resulting in a heightened likelihood of recurrence or metastasis.

In contrast to other breast cancer types, which typically see a five-year survival rate of around 28%, TNBC has a dismally lower rate of 12%. Early reoccurrence highlights the need for effective therapies like sacituzumab govitecan.

Sacituzumab Govitecan – A Key Player

Sacituzumab govitecan is a first-in-class antibody-drug conjugate targeting TROP-2, a cell surface antigen prevalent in over 90% of breast cancers. The innovative design of the drug binds a topoisomerase I inhibitor to the antibody, effectively delivering its payload directly to TROP-2 positive cells. It has received approval in various countries as a treatment for metastatic and recurrent TNBC, and its use has been documented in over 75,000 patients since 2020.

Conclusion

Gilead’s positive opinion from CHMP marks a potentially transformative moment for TNBC patients. By paving the way for new treatment pathways and affirming Gilead's role in championing advancements in oncology, the future of combating this aggressive cancer could take a promising turn with the integrative use of sacituzumab govitecan and pembrolizumab. As the medical community awaits the European Commission's final decision, the hope is to enhance outcomes for thousands affected by TNBC across Europe.