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. 2024 Dec 18;17(12):1713.
doi: 10.3390/ph17121713.

Immune Checkpoint Blockade Combined with AbnobaViscum® Therapy Is Linked to Improved Survival in Advanced or Metastatic Non-Small-Cell Lung Cancer Patients: A Registry Study in Accordance with the ESMO Guidance for Reporting Real-World Evidence

Friedemann Schad  1   2 , Anja Thronicke  1 , Ralf-Dieter Hofheinz  3 , Reinhild Klein  4 , Patricia Grabowski  2   5 , Shiao Li Oei  1 , Hannah Wüstefeld  6 , Christian Grah  6
Affiliations

Immune Checkpoint Blockade Combined with AbnobaViscum® Therapy Is Linked to Improved Survival in Advanced or Metastatic Non-Small-Cell Lung Cancer Patients: A Registry Study in Accordance with the ESMO Guidance for Reporting Real-World Evidence

Friedemann Schad et al. Pharmaceuticals (Basel). .

Abstract

Background: Recent advancements in cancer treatment have shown the potential of immune checkpoint blockade (ICB) plus Viscum album L. therapy in improving survival rates for patients with advanced or metastatic non-small-cell lung cancer (NSCLC). The objective of this study was to investigate factors associated with improved survival in NSCLC patients treated with a combination of ICB and abnobaViscum®. Methods: Patients with advanced or metastatic NSCLC from the accredited Network Oncology registry were included in this real-world data study adhering to ESMO-GROW criteria with ethics approval. Survival outcomes were compared between patients receiving ICB therapy alone versus those receiving combinational ICB plus abnobaViscum® therapy using Kaplan-Meier and multivariable Cox proportional hazard analysis. Results: Among 300 patients (median age 68 years; male/female ratio 1.19), 222 received ICB alone (CTRL group) and 78 received combinational therapy (COMB group). Overall survival was significantly prolonged in the COMB group by 7 months compared to CTRL (13.8 months vs. 6.8 months, p = 0.005) with a survival rate of 16.5% in the COMB group vs. 8.0% in the CTRL group. In programmed death-ligand 1 positive (≥1%) patients treated with first-line ICB, the addition of abnobaViscum® reduced the adjusted hazard of death by 75% (aHR: 0.25; 95%CI: 0.11-0.60, p = 0.02). Conclusions: The addition of abnobaViscum® to ICB is significantly associated with improved survival in patients with advanced or metastatic NSCLC patients, irrespective of age, stage, Eastern cooperative oncology group status, surgery, or radiation. Potential mechanisms include immune modulation, reduced primary ICB resistance, and tumor microenvironment modifications. The findings warrant further validation in randomized controlled trials or registry-based randomized controlled trials. Trial registration: The study was registered (DRKS00013335).

Keywords: PD-1 inhibitor; PD-L1 inhibitor; abnobaViscum® therapy; lung cancer; non-small-cell lung cancer; survival.

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Conflict of interest statement

F.S. reports receiving grants from ABNOBA GmbH, Helixor Heilmittel GmbH, and Astrazeneca GmbH, outside the submitted work. RDH reports a consulting or advisory role with Amgen, Roche, Merck, Sanofi, Bayer, Ipsen, BMS, and MSD, as well as honoraria from Amgen, AstraZeneca, Bayer, BMS, Boehringer, Ipsen, Lilly, Medac, Merck, MSD, Roche, Saladax, and Sanofi, all outside the submitted work. RDH has also received research grants from Amgen, Medac, Merck, Roche, Saladax, and Sanofi, outside the submitted work. PG reports travel expenses from Ipsen Pharma and research grants from Helixor Heilmittel GmbH, outside the submitted work. H.W. reports honoraria from AstraZeneca and Berlin-Chemie, outside the submitted work. C.G. reports honoraria from AstraZeneca, Novartis, Chiesi, the German Society of Pneumology, Takeda, the German S3-Guideline on Complementary Medicine in the Treatment of Oncological Patients, and the Brandenburgian Cancer Society, all outside the submitted work. C.G. has also received grants from Wala AG and Iscador AG, outside the submitted work. C.G. is a member of the European Respiratory Society, the German Society of Pneumology, Health Care Without Harm, the German Alliance for Climate Change and Health, and the Society of Anthroposophic Physicians. The remaining authors declare no competing interests.

Figures

Figure 1
Figure 1
Study process flow. Patients with advanced or metastatic NSCLC who received PD-1/PD-L1 inhibitors, either with or without abnobaViscum® therapy (n = 300), CRTL, received PD-1/PD-L1 inhibitors and no abnobaViscum® therapy; COMB, received PD-1/PD-L1 inhibitors in conjunction with abnobaViscum® therapy; ICB, immune checkpoint blockade; n, number; abnobaViscum®, abnobaViscum® therapy; PD-L1 ≥1%, ≥1% tumor proportion score of programmed death-ligand 1.
Figure 2
Figure 2
Characterization of combinational PD-1/PD-L1 inhibitor and abnobaViscum® therapy. Abnoba, abnobaViscum® therapy; iv, intravenous; sc, subcutaneous; it, intratumoral. Numbers are indicated as percent of patients.
Figure 3
Figure 3
Kaplan–Meier survival curves displaying overall survival according to treatment in advanced or metastatic NSCLC (n = 300); Log-rank test: X2 = 7.9, p = 0.005; Ctrl, PD-1/PD-L1 inhibitors; Comb, PD-1/PD-L1 inhibitors + abnobaViscum® therapy.
Figure 4
Figure 4
Summative figure of the study’s findings.
See this image and copyright information in PMC

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