Genentech, part of the Roche Group, has provided an update on the Phase III SKYSCRAPER-01 study, which evaluated the combination of tiragolumab with Tecentriq® (atezolizumab) compared to Tecentriq alone in patients with PD-L1-high, locally advanced or metastatic non-small cell lung cancer (NSCLC).
The SKYSCRAPER-01 trial is a global, randomized, double-blind study that aimed to assess the efficacy and safety of tiragolumab plus Tecentriq versus Tecentriq alone. The study enrolled 534 patients with PD-L1-high, previously untreated, locally advanced unresectable, or metastatic NSCLC. These patients were randomized to receive either tiragolumab combined with Tecentriq or a placebo plus Tecentriq until disease progression, loss of clinical benefit, or unacceptable toxicity. Despite rigorous testing, the study did not meet its primary endpoint of overall survival at the final analysis. Importantly, the safety profile of the combination treatment was consistent with earlier observations, with no new safety concerns identified. Detailed data from the study will be presented at a medical conference in 2025.
Genentech continually evaluates its clinical trial programs to determine necessary adjustments and ensure the ongoing advancement of research. The company plans to incorporate additional findings from Phase III trials across various tumor types and treatment settings, with more data expected next year.
About Tiragolumab
Tiragolumab is an investigational immune checkpoint inhibitor that specifically targets TIGIT, a novel immune checkpoint protein involved in suppressing the immune system’s response to cancer. By blocking TIGIT, tiragolumab may enhance immune cell activity against tumor cells.
About Tecentriq® (Atezolizumab)
Tecentriq is a monoclonal antibody that targets PD-L1, a protein expressed on tumor cells and tumor-infiltrating immune cells. By binding to PD-L1, Tecentriq prevents it from interacting with the PD-1 and B7.1 receptors, allowing T cells to re-activate and mount a stronger immune response against the tumor. Tecentriq is approved for various indications, including the treatment of non-small cell lung cancer (NSCLC).
Tecentriq Indications in the U.S.
Tecentriq is approved for the treatment of adult patients with PD-L1-positive NSCLC. It can be used as a monotherapy to prevent cancer recurrence after surgery and chemotherapy in patients with stage 2 to 3A NSCLC. It is also used as first-line treatment for metastatic or unresectable NSCLC with high PD-L1 expression and no EGFR or ALK gene mutations. Additionally, Tecentriq is administered in combination with chemotherapy for advanced non-squamous NSCLC that lacks EGFR or ALK mutations. In cases where patients have already received platinum-based chemotherapy, Tecentriq may be used as a subsequent treatment option.
Important Safety Information
Tecentriq can cause severe immune-mediated side effects that affect organs and tissues throughout the body. These problems can become life-threatening and even result in death. Patients may experience symptoms affecting the lungs, liver, intestines, hormones, kidneys, skin, and other organs, sometimes simultaneously. It is crucial for patients to contact their healthcare provider immediately if they experience any new or worsening symptoms, such as:
- Lung issues: Cough, shortness of breath, chest pain
- Intestinal issues: Diarrhea, blood in stools, abdominal pain
- Liver problems: Jaundice, nausea, abdominal pain, dark urine
- Hormonal issues: Unexplained headaches, vision changes, weight changes, excessive sweating, fatigue
- Kidney problems: Decreased urine output, blood in urine, swelling in ankles
- Skin reactions: Rash, itching, mouth sores, fever
The risk of these side effects may lead healthcare providers to temporarily or permanently stop Tecentriq treatment. Patients are also advised to inform their doctors about any existing medical conditions, including immune disorders, organ transplants, and pregnancy plans, as Tecentriq may have harmful effects during pregnancy and breastfeeding.
Common Side Effects
The most common side effects of Tecentriq include fatigue, decreased appetite, nausea, and shortness of breath. In combination with other anti-cancer medications, patients may also experience hair loss, constipation, and diarrhea. Tecentriq may cause fertility issues in women, potentially affecting their ability to conceive. Patients are advised to consult their healthcare providers if they have concerns about fertility.
