Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Tecemotide (L-BLP25)
Tecemotide · 6 trials · 5 indications
Overall survival time was defined as the time from randomization to death. Participants without events were censored at the last date they were known to be alive or the clinical cut-off date, whatever was earlier.
Tumor biopsy samples were collected prior to baseline and after the surgery. The TILs were evaluated in 3 of the most abundant high-power fields (x40) per sample and the mean value considered (after excluding the lowest and the highest value). The tumor immune response was calculated as number of TILs divided by 100 tumor cells.
A potential association between MSI status (present or absent) and the primary endpoints (difference from baseline to surgery in CD8+ and CD8+/GrB+ T cell infiltration) was evaluated. Determination of mismatch repair protein (MRP)-expression (hMLH1, hMSH2, hMSH6 and hPMS2) was performed for the detection of the MSI-H-phenotype by IHC and/or on tumor deoxyribonucleic acid (DNA) sample using 5 microsatellite markers (BAT-25, BAT-26, NR-21, NR-24 and MONO-27).
IFN-gamma secretion of mononuclear cells in response to MUC1 was to be measured by ELISpot. The maximal post-baseline value out of Week 5, Week 11-13 (pre-surgery), and Week 16-18 (follow-up / end-of trial) was evaluated in comparison to Baseline.
IFN-gamma secretion of mononuclear cells in response to CEA was to be measured by ELISpot. The maximal post-baseline value out of Week 5, Week 11-13 (pre-surgery), and Week 16-18 (follow-up / end-of trial) was evaluated in comparison to Baseline.
The overall immune response was achieved at least for 2 timepoints; that is at least 1 parameter in at least 1 assay (Lymphoproliferation assay, enzyme-linked immunospot (ELISPOT) for interferon \[IFN\] gamma, and intracellular IFN gamma cytokine assay in peripheral blood mononuclear cell \[PBMC\]) with ratio to background \>=2, and ratio of background-corrected value to baseline \>=2;Specific immune response at a given timepoint 't' was considered as differences of log-scale values under stimulation (X vax,t ) to those of the respective unstimulated controls (Xneg,t, background values)were computed after certain assay-specific pre-processing steps: Yt = Xvax,t - Xneg,t; A participant was considered to show positive stimulation-induced immune response at timepoint 't' (POS\[t\]=1), upon fulfilling the following criteria: Yt =\>1 (That is at least a 2-fold higher value under stimulation than without stimulation). AVvax,t-1SEM vax,t \> AVneg,t+1SEMneg,t (ELISPOT and proliferation assay only).
TEAEs occurred between the first dose of study drug and up to 42 days after the last dose that were absent before treatment or that worsened relative to pretreatment state. A serious TEAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs with Cancer and Leukemia Group B Extended Clinical Toxicity Criteria (CALGB-ECTC) Grade 3 or 4 were also reported.
An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. A serious AE was an AE that results in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with TEAEs, serious TEAEs, TEAEs leading to death, and TEAEs with CALGB toxicity Grade 3 or 4 were reported.
Time from randomization to death or last day known to be alive. Participants without event were censored at the last date known to be alive or at the clinical cut-off date (15 March 2006), whichever was earlier.
OS time was defined as the time from randomization to death. Participants without event were censored at the last date known to be alive or at the clinical cut-off date (01 May 2014), whichever was earlier.
| Arm | Type | Description |
|---|---|---|
| Tecemotide (L-BLP25) | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Chemoradiotherapy+tecemotide (L-BLP25)+CPA | EXPERIMENTAL | - |
| Chemoradiotherapy+tecemotide (L-BLP25) | EXPERIMENTAL | - |
| Chemoradiotherapy | ACTIVE_COMPARATOR | - |
| Tecemotide (L-BLP25) plus single low dose cyclophosphamide | EXPERIMENTAL | - |
| Tecemotide (L-BLP25) plus multiple low dose cyclophosphamide | EXPERIMENTAL | - |
| Tecemotide(L-BLP25)+Cyclophosphomide+best standard of care | EXPERIMENTAL | - |
| Tecemotide (L-BLP25) plus Best Supportive Care (BSC) | EXPERIMENTAL | - |
| Best Supportive Care (BSC) Alone | ACTIVE_COMPARATOR | - |
| Tecemotide (L-BLP25) + Cyclophosphamide | EXPERIMENTAL | Active |
| Placebo + Saline | PLACEBO_COMPARATOR | Control |
| Name | Type | Description |
|---|---|---|
| Tecemotide (L-BLP25) | BIOLOGICAL | After receiving cyclophosphamide, participants will receive 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 806 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until disease progression is documented. |
| Single low dose cyclophosphamide | DRUG | A single intravenous infusion of 300 milligram per square meter (mg/m\^2) (to a maximum 600 mg) of cyclophosphamide will be given 3 days before first tecemotide (L-BLP25) vaccination. |
| Placebo | DRUG | A single infusion (IV) of 0.9% Saline solution instead of cyclophosphamide but in the same calculated dose will be given three days before first placebo vaccination. Subjects will then receive eight consecutive weekly subcutaneous vaccinations with placebo at weeks 0; 1; 2; 3; 4; 5; 6 and 7 followed by maintenance placebo vaccinations at 6-week intervals, commencing at week 13, until disease progression is documented. |
| cyclophosphamide (CPA) | DRUG | A single intravenous infusion of 300 milligram per square meter (mg/m\^2) (to a maximum 600 mg) of CPA will be given 3 days before the first tecemotide (L-BLP25) administration. |
| Chemoradiotherapy | OTHER | Radiotherapy of 45-52 grays (Gy) will be applied 5 times per week, over a minimum period of 5 weeks. Capecitabine at a dose of 825 mg/m\^2, twice daily or equivalent dose of 5-fluorouracil (5-FU) will be given orally, starting at the first day of radiotherapy and given 5 to 7 days per week during the time of radiotherapy. |
| Multiple low dose cyclophosphamide | DRUG | An IV infusion of 300 mg/m\^2 (to a maximum 600 mg) of cyclophosphamide will be given 3 days before the first vaccine treatment plus an intravenous dose of cyclophosphamide (300 mg/m\^2, to a maximum of 600 mg) 3 days prior to the tecemotide (LBLP25) administration at week 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week 14 up to a maximum treatment period of 2 years. |
| Best standard of care (BSC) | OTHER | The BSC will be provided at the investigator's discretion, and may include but not be limited to psychosocial support, nutritional support and other supportive therapies. |
| Best Supportive Care (BSC) | OTHER | The BSC will be provided at the investigator's discretion, and may include palliative radiation, psychosocial support, analgesics and nutritional support. Second-line chemotherapy is permitted when indicated for treatment of progressive disease. |
| Saline | OTHER | A single dose of saline (sodium chloride, 9 grams per liter \[g/L\]) will be administered intravenously, 3 days prior to the start of placebo. |
Inclusion Criteria: * Histologically or cytologically documented unresectable stage III non-small cell lung cancer (NSCLC) * Documented stable disease or objective response, according to Response Evaluation Criteria in Solid Tumors (RECIST), after primary chemoradiotherapy (either sequential or con...
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Tecemotide is an investigational cancer vaccine that has been studied in non-small cell lung cancer, rectal cancer, and multiple myeloma. It is not approved for commercial use. Clinical development has focused on patients with unresectable Stage III NSCLC after primary chemoradiotherapy, as well as slowly progressive multiple myeloma and rectal cancer.
Tecemotide targets MUC1, a tumor-associated antigen. It is a vaccine antigen designed to stimulate an immune response against cells expressing MUC1. The molecule is classified as a monoclonal antibody modality in this vaccine antigen class.
Tecemotide is developed by Merck KGaA, which trades under the ticker MKGAF. The company has sponsored the clinical trial program for the drug across multiple cancer indications.
Tecemotide is in Phase 2 development. It is investigational and has not been approved by the FDA. The program includes completed Phase 1, Phase 2, and Phase 3 trials, with no active trials currently listed.
Tecemotide has been evaluated in completed trials including NCT01507103 in rectal cancer, NCT01094548 in multiple myeloma, NCT00960115 in Stage III unresectable NSCLC, and the Phase 3 START trial NCT00409188 in unresectable Stage III NSCLC. All four studies are completed.
Yes, Tecemotide is also known as L-BLP25. Both names refer to the same investigational cancer vaccine developed by Merck KGaA. The L-BLP25 designation appears in the trial titles for the rectal cancer, multiple myeloma, and NSCLC studies.