Summary: A 2021 clinical trial demonstrates that Nabiximols (Sativex), an FDA-approved oromucosal spray with 1:1 ratio of CBD:THC, improves temozolomide's (TMZ) effectiveness in treating glioblastoma, an aggressive type of cancer that originates in the brain or spinal cord, potentially improving patient outcomes.

This research offers a promising new approach to potentially extending the survival of glioblastoma patients, a group that has historically faced limited treatment options, poor prognoses, and high mortality rates. While other agents have been tested, cannabinoids are the first to have the efficacy, low toxicity, tolerability, and brain-blood barrier penetration demonstrated in the study.

  • Cannabinoids as Add-on Brain Cancer Treatment:

    Nabiximols, a cannabinoid spray with a 1:1 ratio of CBD:THC, has shown potential as a safe adjunctive treatment with temozolomide (TMZ) for recurrent glioblastoma, demonstrating a tolerable safety profile. There were no apparent effects of either cannabinoid on TMZ.

  • Nabiximols (Satived) Doubled One-Year Survival Rates:

    Patients treated with Nabiximols exhibited a higher one-year survival rate (83% survived) in comparison to those receiving a placebo (44% survived), suggesting a significant survival benefit.

  • Modulating the Tumor Microenvironment

    CBD and THC have both direct and indirect effects on cancer cells. Directly, they enhance the treatment of glioblastoma by inducing tumor cell death, inhibiting cell proliferation, and preventing the formation of new blood vessels within the tumor, without affecting the pharmacokinetics of temozolomide. Indirectly, CBD and THC are found to influence the tumor microenvironment, altering the surrounding tissues and immune cells in a way that contributes to a more effective fight against cancer.

A 2021 randomised, placebo-controlled trial, led by researchers from the University of Leeds' Leeds Institute of Medical Research and the St. James University Hospital's Department of Oncology, presents novel findings on the safety and efficacy of nabiximols, an oromucosal spray with a 1:1 blend of CBD:THC, in combination with temozolomide (TMZ) chemotherapy for patients with recurrent glioblastoma (GBM). Results were promising, showing that nabiximols is well-tolerated and could be personalized for individual dosing.

Most notably, the trial reported a significant increase in one-year survival rates for patients treated with nabiximols compared to those on placebo, suggesting an improvement in treatment outcomes for GBM. These findings highlight the medical significance of cannabinoids as a complementary therapy in GBM, offering new hope for extending patient survival in a disease with very few effective treatment options.

CBD and THC: A new hope for glioblastoma patients?

In the relentless battle against glioblastoma (GBM), the most aggressive form of brain cancer, a ray of hope emerges from the synergy of cannabinoids and chemotherapy.

A recent Phase 1b clinical trial has shed light on the potential of nabiximols, a cannabinoid oromucosal spray, to extend the lives of patients suffering from recurrent GBM when combined with the chemotherapy drug temozolomide (TMZ).

The trial was divided into two parts: an open-label phase and a randomized, placebo-controlled phase. Both phases aimed to evaluate the safety and preliminary efficacy of nabiximols in conjunction with dose of TMZ.

The results were promising, with the nabiximols group showing a one-year survival rate of 83% compared to 44% for the placebo group. This significant difference, although based on a small sample size, suggests that cannabinoids could play a crucial role in improving outcomes for GBM patients.

The trial’s findings also indicate that nabiximols is well-tolerated and can be personalized to each patient’s needs without interfering with the pharmacokinetics of TMZ. The median overall survival (OS) for patients treated with nabiximols was estimated at 21.8 months, markedly higher than the 12.1 months for those on placebo. These figures are particularly striking considering the typically dismal prognosis for recurrent GBM.

The trial’s strengths lie in its personalized approach and rigorous placebo control, which lend credibility to the survival benefits observed. However, limitations such as the small number of participants and potential imbalances in patient characteristics warrant cautious interpretation of the results. The trial’s design did not account for detailed tumor classification or the impact of post-trial treatments, which could influence survival outcomes.

The trial concludes that nabiximols, in combination with TMZ, is a feasible and safe treatment option for recurrent GBM patients.

While the observed survival benefits are encouraging, they underscore the need for further research through a larger, adequately powered randomized controlled trial. The journey to find a cure for GBM is fraught with challenges, but this study offers a glimmer of hope and a potential new avenue for treatment that could change the lives of those affected by this devastating disease.

Read: CBD With TMZ May Improve Brain Cancer Survival Rates

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About this psychopharmacology research news.

Author: Susan C. Short
Source: Nature
Contact:  Susan C. Short, University of Leeds
Original Research: Open access.
A phase 1b randomised, placebo-controlled trial of nabiximols cannabinoid oromucosal spray with temozolomide in patients with recurrent glioblastoma" by Liliana Soroceanu and Sean McAllister et al., British Journal of Cancer

Simple summary.

The clinical trial explored the efficacy of nabiximols, a cannabinoid spray containing THC and CBD, in conjunction with temozolomide chemotherapy for patients with recurrent glioblastoma. The study found that nabiximols was well-tolerated and personalized dosing was feasible, with no significant impact on the pharmacokinetics of temozolomide. Importantly, the trial reported a notable increase in one-year survival rates for patients receiving nabiximols compared to the placebo group, suggesting that cannabinoids may have a beneficial role in glioblastoma treatment, meriting further research in larger, controlled trials to confirm these preliminary findings and to understand the mechanisms by which cannabinoids may influence tumor behavior and patient survival.


Background: Preclinical data suggest some cannabinoids may exert antitumour effects against glioblastoma (GBM). Safety and preliminary efficacy of nabiximols oromucosal cannabinoid spray plus dose-intense temozolomide (DIT) was evaluated in patients with first recurrence of GBM.

Methods: Part 1 was open-label and Part 2 was randomised, double-blind, and placebo-controlled. Both required individualised dose escalation. Patients received nabiximols (Part 1, n = 6; Part 2, n = 12) or placebo (Part 2 only, n = 9); maximum of 12 sprays/day with DIT for up to 12 months. Safety, efficacy, and temozolomide (TMZ) pharmacokinetics (PK) were monitored.

Results: The most common treatment-emergent adverse events (TEAEs; both parts) were vomiting, dizziness, fatigue, nausea and headache. Most patients experienced TEAEs that were grade 2 or 3 (CTCAE). In Part 2, 33% of both nabiximols- and placebo-treated patients were progression-free at 6 months. Survival at 1 year was 83% for nabiximols- and 44% for placebo-treated patients (p = 0.042), although two patients died within the first 40 days of enrolment in the placebo arm. There were no apparent effects of nabiximols on TMZ PK.

Conclusions: With personalised dosing, nabiximols had acceptable safety and tolerability with no drug–drug interaction identified. The observed survival differences support further exploration in an adequately powered randomised controlled trial.

Clinical Trial Registration: Part 1– NCT01812603; Part 2– NCT01812616.

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