Racotumomab is the second vaccine for non-small cell lung cancer (NSCLC). It “targets” the tumor-associated ganglioside (NeuGcGM3) in cancer cells, causing patients to mount an immune response that kills tumor cells.
Racotumomab, a vaccine for lung cancer treatment, has shown promising results in clinical trials, significantly improving patient survival with a favorable safety profile and a common side effect of mild redness at the injection site. Clinical trials are underway in several countries around the world.
Effective treatment for advanced NSCLC that is stable after chemotherapy
A study looked at the efficacy of Racotumomab in treating patients with advanced (stage IIIb/IV) NSCLC who had stable disease after first-line chemotherapy. The results showed that patients in the vaccine group had longer median overall survival (OS) (8.23 months versus 6.80 months) and longer median progression-free survival (PFS) (5.33 months versus 3.90 months) compared with placebo.
In addition, patients in the vaccine group had 1- and 2-year survival rates of 40.2% and 18.4%, respectively, compared with 22.5% and 6.7% in the placebo group.
In another study, NeuGcGM3 antibodies were observed in the serum of 11 of 12 NSCLC patients after maintenance treatment with Racotumomab vaccine, and they had a PFS of 13.8 months, including up to 21 months in one stage IIIB patient. This suggests that the benefit of racotumomab treatment correlates with the cytotoxicity of the patient to the tumor.
Prospects to be the best maintenance treatment for NSCLC
A phase III clinical trial showed that patients in the Racotumomab group had a PFS of 9.67 months and a 1-year survival rate of 45.5% as a second-line or maintenance regimen for patients with NSCLC, compared with 9.76 months and 33.5% for docetaxel, respectively. This suggests that Racotumomab is no less effective than docetaxel as maintenance therapy for patients with NSCLC.
So, does Racotumomab work as well as similar vaccines? One study analyzed 2 trials, Trial 1 compared Racotumomab to placebo and Trial 2 compared CIMAvaxEGF, another lung cancer vaccine, to best supportive care. The results found:
(1) Racotumomab did not prolong median overall survival (OS) compared with placebo in patients with shorter survival; however, there was a significant prolongation of median OS in patients with longer survival (76.6 months versus 33.8 months);
(2) CIMAvaxEGF significantly prolonged median OS compared with best supportive care in both shorter and longer survival patients, with a median OS of 61.8 months in the CIMAvaxEGF group (33.8 months in the control group) in patients with longer survival.
This study suggests that the two lung cancer vaccines work differently in patients with different survival, and that Racotumomab may work better in patients with longer survival. However, it is important to note that this was not a direct comparison of the two vaccines in one study, so the study data should be used only as a reference.
The researchers combined 26 clinical trials involving 7839 patients with stage III/IV NSCLC to show that racotumomab may be the best option for maintenance therapy after first-line treatment in the stable phase.
Current studies
A phase III study (NCT01460472) enrolling patients with intermediate to advanced NSCLC will compare the safety and tolerability of best supportive care alone versus in combination with Racotumomab.
Summary
With continued advances in molecular biology and standardization of the vaccine preparation process, lung cancer vaccines will play an important role in the comprehensive treatment of lung cancer. racotumomab as a maintenance regimen after first-line therapy for patients with stage III/IV NSCLC not only prolongs overall and progression-free survival, but is no less effective than chemotherapy. Clinical trials are currently underway in multiple countries.