Vaxira (racotumomab) / PT Kalbe Farma, CIMAB, Eurofarma, Recombio - LARVOL DELTA

Therapeutic vaccines for advanced non-small cell lung cancer. (PubMed, Cochrane Database Syst Rev) - "Adding a vaccine resulted in no differences in overall survival, except for racotumomab, which showed some improvement compared to placebo, but the difference in median survival time was very small (1.4 months) and the study only included 176 participants. Regarding progression-free survival, we observed no differences between the compared treatments, except for TG4010, which may increase progression-free survival slightly. There were no differences between the compared treatments in serious treatment-related adverse events, except for SRL172 (killed Mycobacterium vaccae) added to chemotherapy, which was associated with an increase in the proportion of participants with at least one serious treatment-related adverse event, and OSE2101, which may decrease slightly the proportion of people having at least one serious treatment-related adverse event. These conclusions should be interpreted cautiously, as the very low- to moderate-certainty evidence prevents drawing solid ..."

Journal • Metastases • Review • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Racotumomab in Patients With High-risk Neuroblastoma (clinicaltrials.gov) - P2 | N=39 | Completed | Sponsor: Laboratorio Elea Phoenix S.A. | Active, not recruiting ➔ Completed | Trial primary completion date: Aug 2022 ➔ Nov 2022

IO biomarker • Trial completion • Trial primary completion date • CNS Tumor • Neuroblastoma • Neuroendocrine Tumor • Oncology • Solid Tumor

Vaccines and monoclonal antibodies in the prolonged treatment of non-small cell lung cancer: 20 years of follow-up (IVC-MG 2023) - "After analyzing more than 3,900 patients in a database integrated with all the clinical trials conducted in the period from 2002 to 2020 with the Cimavax EGF and Vaxira vaccines and the humanized monoclonal antibody nimotuzumab, it was found that around 20% of the patients  had a long survival, greater than 24 months, when they were treated with immunotherapies; but also that a group of patients who were controls in these studies were long survivors. Depending on the product analyzed, predictive parameters of a good response to these treatments were identified, leading to the creation of a therapeutic algorithm to select the appropriate therapy. These parameters are related to the inflammatory level such as the NLR, the PLR and the histological type of the disease."

Immune Modulation • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Racotumomab in Patients With High-risk Neuroblastoma (clinicaltrials.gov) - P2; N=39; Active, not recruiting; Sponsor: Laboratorio Elea Phoenix S.A.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • IO biomarker • Neuroblastoma • Oncology • Solid Tumor

Racotumomab in Patients With High-risk Neuroblastoma (clinicaltrials.gov) - P2; N=39; Recruiting; Sponsor: Laboratorio Elea Phoenix S.A.; Trial completion date: Jun 2021 ➔ Sep 2022; Trial primary completion date: Jun 2021 ➔ Aug 2022

Clinical • IO biomarker • Trial completion date • Trial primary completion date • Neuroblastoma • Oncology • Solid Tumor

Racotumomab in Non-Small Cell Lung Cancer as Maintenance and Second-Line Treatment. (PubMed, MEDICC Rev) - "Racotumomab in routine clinical practice prolonged overall survival in patients with non-small cell lung cancer treated in switch maintenance, and in stage IV patients who received the treatment as second-line therapy. The vaccine was well tolerated."

Clinical • Journal • Immunology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

The Rapid Development and Early Success of Covid 19 Vaccines Have Raised Hopes for Accelerating the Cancer Treatment Mechanism. (PubMed, Arch Razi Inst) - "An example of an anti-idiotype antibody is Racotumomab or Vaxira (Cancer, 2016)...There are currently FDA-approved products for helping cancer treatment such as BREYANZI, TECARTUS and YESCARTA for lymphoma, IMLYGIC for melanoma, KYMRIAH for acute lymphoblastic leukemia, and PROVENGE for prostate cancer...The current pandemic situation has necessitated the acceleration of Covid 19 vaccines and drugs and national and international protocols for their approval. If the currently produced vaccines can continue to be as successful as the preclinical and early phase studies, these changes and evolution have raised hopes for accelerating the use of these technologies and mechanisms in the field of cancer and other diseases vaccines, including HIV and influenza."

Journal • Acute Lymphocytic Leukemia • Breast Cancer • Genito-urinary Cancer • Hematological Malignancies • Human Immunodeficiency Virus • Infectious Disease • Leukemia • Lymphoma • Melanoma • Novel Coronavirus Disease • Oncology • Prostate Cancer • Respiratory Diseases • Solid Tumor

Racotumomab in Patients With High-risk Neuroblastoma (clinicaltrials.gov) - P2; N=39; Recruiting; Sponsor: Laboratorio Elea Phoenix S.A.; Trial primary completion date: Dec 2020 ➔ Jun 2021

Clinical • IO biomarker • Trial primary completion date • Neuroblastoma • Oncology • Solid Tumor

Prognostic Significance of Tumor Tissue NeuGcGM3 Ganglioside Expression in Patients Receiving Racotumomab Immunotherapy. (PubMed, J Oncol) - "Mean OS of the patient with more than 10 Racotumomab application was significantly longer than the patient who had less than 10 injections (70.7 months vs. 31.1 months, p < 0.001). We propose that, regardless of staining intensity, the presence of NeuGcGM3 in patient tissues might be an indicator of benefit in Racotumomab treatment."

Clinical • IO Biomarker • Journal • Oncology

[VIRTUAL] Racotumomab and PD-1 blockade combination exhibits an additive antitumor effect in a non-small cell lung cancer model (AACR-II 2020) - "Combinatorial approaches involving long-term immunization against tumor-specific antigens together with the anti-PD1 immune-checkpoint inhibitor pembrolizumab is an attractive strategy for immunotherapy. Interestingly, sequential administration of anti-PD1 therapy followed by repeated immunizations with racotumomab-alum was highly effective against lung nodules and well tolerated, showing a reduction in nodules formation of 62 and 45% compared to anti-PD1 or racotumomab-vaccinated groups, respectively (p<0.01, ANOVA followed by Tukey). Our preclinical data provide support for the combination of anti-PD1 checkpoint blockade with the anti-idiotype monoclonal antibody racotumomab in advanced NSCLC, since combination treatment has a significant additive antitumor effect compared to each individual treatment."

IO Biomarker • Preclinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer

Racotumomab administration in patients with advanced non-small-cell lung cancer (NSCLC) in progression after first line therapy (LALCA 2012) - P=NA, N=180; Median survival was 12 months; Long term OS rate at 24 months was 30%; Median survival in the control group was 6.26 months (p= 0.011); Long term OS rate at 24 months was only 7%

Clinical data • Non Small Cell Lung Cancer

Combination of platinum standard first front line chemotherapy and Vaxira vaccine in patients with advanced non- small- cell lung cancer (LALCA 2014) - Abstract #PD.2; P1, N=20; “Median survival was 12.94 months. The combination was safe since the vaccination did not add toxic effects to the first lines of oncospecific therapy. All patients developed high antibody responses against Racotumomab MAb during the vaccination schedule.” 

P1 data • Non Small Cell Lung Cancer • Oncology

Racotumomab in Patients With High-risk Neuroblastoma (clinicaltrials.gov) - P2; N=39; Recruiting; Sponsor: Laboratorio Elea S.A.C.I.F. y A.; Trial completion date: Jun 2020 ➔ Jun 2021; Trial primary completion date: Nov 2019 ➔ Dec 2020

Clinical • IO Biomarker • Trial completion date • Trial primary completion date

Prognostic significance of tumour tissue NeuGcGM3 ganglioside expression and predictive value of circulating tumour cell count monitoring in patients receiving racotumomab immunotherapy (ESMO 2019) - "This study revealed that any grade of NeuGcGM3 positivity in the tumor tissue is adequate to select a patient for Racotumomab treatment regardless of the IHC intensity. We also concluded that CTC monitoring in patients receiving immunotherapy is a good predictive and prognostic tool. Legal entity responsible for the study: Necdet Uskent."

Circulating Tumor Cells • Clinical • IO Biomarker • PD(L)-1 Biomarker