Kidney Cancer

February 18, 2013

AVEO Oncology and Astellas Pharma reported results from a phase III trial of tivozanib compared to sorafenib for the treatment of advanced renal cell carcinoma (RCC). This global, randomized study, TIVO-1, enrolled 517 patients with RCC. Subjects received either tivozanib or sorafenib. The final overall survival (OS) analysis showed a median OS of 28.8 months (95% confidence interval [CI]: 22.5–NA) for tivozanib versus a median OS of 29.3 months (95% CI: 29.3–NA) for the comparator arm, sorafenib. No statistical difference between the two arms (HR=1.245, p=0.105) was observed. Patients randomized to the sorafenib arm were eligible to cross over to tivozanib therapy under a separate protocol after radiographic confirmation of disease progression. No crossover protocol was available for patients randomized to the tivozanib arm. Tivozanib was well tolerated. Based on these data, AVEO and Astellas have filed a New Drug Application (NDA) for tivozanib for the treatment of RCC.

November 28, 2011

Mologen released results from a phase I/II trial of MGN1601, a therapeutic vaccine for the treatment of renal cancer. This open, non-randomized study enrolled 19 subjects in whom the standard treatment proved to be unsuccessful. The subjects were treated with MGN1601 several times over a period of 12 weeks. Nine subjects completed the full three month treatment cycle. In one subject the size of the metastases was reduced by more than 50%, and in two cases the progress of renal cancer was stopped. Two subjects are still on treatment and the therapeutic success with these two subjects has lasted for more than six months. One subject is in the first phase of the trial. MGN1601 was well tolerated and no serious adverse effects were reported. Due to these results, enrollment was stopped early and the treatment of the remaining three subjects will continue as planned.

October 16, 2006

Immatic's reported positive results from a phase I trial of IMA901, a renal cell cancer vaccine. This trial enrolled 28 subjects across six centers in Germany, the United Kingdom and Switzerland. Treatment was safe and well tolerated. Efficacy data revealed that 70% of the treated subjects displayed immune responses against tumor-associated antigens included in the IMA901 vaccine. This formation of immune responses against multiple targets correlated significantly with a stabilization of the disease and a decline in the tumor burden identified prior to commencement of the treatment (p<0.05). Based on these results Immatic's plans to initiate phase II trials by early 2007.

October 9, 2006

PharmaMar released positive results from a phase II trial of Aplidin for the treatment of renal and colorectal cancer. This multi-centre, open-label, randomized trial enrolled 81 subjects with advanced renal or colorectal cancer who were placed in one of two study arms. Arm A subjects were administered Aplidin at a dose of 5 mg/m2 and arm B subjects were administered Aplidin at a dose of 7 mg/m2, in combination with L-carnitine. Safety profiles demonstrated that Apildin at the higher dose, in the combination formula, resulted in a higher incidence of adverse events. Efficacy data revealed that stable disease lasting more than 12 weeks occurred in 32.4% of the renal cancer subjects and in 24.3% of the colorectal cancer subjects. Based on the data development of Aplidin, at the lower dose of 5 mg/m2, will continue forward.

June 13, 2005

Affymax announced positive results of a phase I trial of Hematide, their peptide- based erythropoiesis stimulating agent under investigation for the treatment of anemia in patients with chronic kidney disease (CKD) and cancer. The results were presented at the European Hematology Association meeting in Stockholm. Data produced a met safety endpoints, with no serious adverse events reported and a positive overall tolerability profile. Dose-dependent erythropoietic activity was observed, including increased in circulating reticulocytes. The highest trial dose also produced a statistically significant increase in hemoglobin levels from baseline, which were maintained through one month. This open-label, proof-of-concept study enrolled healthy volunteers, who received single ascending doses of Hematide.

Roche reported positive results of a phase II study of their investigational anti-anemic agent CERA (Continuous Erythropoietin Receptor Activator), at the European Renal Association—European Dialysis and Transplant Association congress in Istanbul. Trial data indicated that the drug produced consistent hemoglobin levels independent of frequency of administration; specifically, dosing once every 4 weeks produced hemoglobin levels of 11.15 g/dL, dosing once every 3 weeks produced levels of 11.18 g/dL, and once weekly dosing achieved levels of 11.33 g/dL. 61 anemic patients on dialysis received one of the three dosing schedules of CERA for 12 months in this randomized, multicenter, dose-ranging study. The company announced that there data would serve to support their ongoing phase III trials of the drug in the treatment of anemia related to CKD, and NDA filing in 2006.

November 1, 2004

Bayer Pharmaceuticals and Onyx Pharmaceuticals announced results from a phase II study of BAY 43-9006, for the treatment of advanced kidney cancer. Trial data met their primary endpoint, with a significantly higher portion of patients receiving BAY 43-9006 maintaining a stable disease state versus subjects receiving placebo. Overall, 70% of study participants receiving the drug demonstrated stable disease state or tumor shrinkage. This multi-center, two-stage, multi-cohort discontinuation trial enrolled a total of 502 subjects, 202 of which had advanced kidney cancer; all subjects received BAY 43-9006 for 12 weeks. Subjects demonstrating stable or similar disease states progressed into a 12 week, placebo-controlled, randomized investigation, while patients showing significant response to the drug entered a parallel open-label phase. The companies announced that the data from this trial would support their ongoing phase III study, which, if successful, would set the likely approval date in 2006.

Cougar Biotechnology announced the combined results of three phase I trials of their investigational drug CB7630 (abiraterone), for the treatment of hormone refractory prostate cancer. Data from all three studies demonstrated preliminary efficacy, achieving significant reductions in serum testosterone levels in two single-dose trials and in one multiple-dose trial. Furthermore, the highest dose in the multiple dose trial suppressed testosterone levels to those comparable to those observed in patients on leutenizing-hormone releasing hormone (LHRH) agonists (>0.7 nmol/L). All three trials investigated dose-ranging regimens of the drug in castrate and non-castrate hormone refractory prostate cancer patients at a single center in the UK; two of the trials investigated single escalating doses, and the third utilized one of two 12 day, dosing regimens.

Peregrine Pharmaceuticals reported positive results of a phase I study of Cotara, their radio-conjugated monoclonal antibody for the treatment of colorectal cancer. The trial found the drug to be safe and well tolerated, with bone-marrow suppression observed as the most frequent dose limiting toxicity, as anticipated. In addition, though no incidence of objective response was noted following single-dose administration, tumor targeting was confirmed via radioimaging, and radiation absorption was much higher in tumor tissue than surrounding organs. This single-agent, single-dose, dose escalating study enrolled patients with advanced refractory colorectal cancer. The company announced that it was working to devise further trials to investigate the drug both as a single agent and adjuvant to other therapies.<

January 19, 2004

Lorus Therapeutics reported interim results a phase II trial investigating GTI-2040, an R2 component of ribonucleotide reductase for the treatment of advanced, end- stage renal cell cancer. Results showed that more than half of subjects exhibited disease stabilization, ranging up to eight months. In some subjects, tumor shrinkage of index tumors compared to baseline measurements was observed. The single-arm pilot study enrolled 21 subjects and was designed to test the safety and efficacy of GTI-2040 used in combination with the anticancer agent capecitabine. Most subjects had failed two or more prior therapies before entering the study, had extensive metastases, and had a very poor prognostic outcome in renal cell cancer.

September 29, 2003

AEterna Laboratories reported negative results from a phase III trial investigating Neovastat, an antiangiogenic compound for the treatment of renal cell carcinoma. Results showed that the study did not meet its primary endpoint of improving overall median survival time. The overall median survival time for the Neovastat group was 12.4 months compared to 12.3 months for the placebo group. Significant survival advantages were observed in a subgroup of subjects with clear cell histology and only a single metastatic site. The randomized, double-blind, placebo-controlled study enrolled 305 subjects and was conducted at 50 sites in Canada, the U.S. and Europe. It was designed to evaluate prolonged survival of subjects with progressive metastatic renal cell carcinoma, refractory to immunotherapy.

Kosan Biosciences reported positive results from a second phase I trial of KOS-862 (Epothilone D), a polyketide tumor cell inhibitor for the treatment of solid tumors. Results showed that a dose of 100mg/m2 weekly for three out of four weeks was well tolerated and was associated with mild to moderate toxicity. Data demonstrated preliminary evidence of anti-tumor activity, including significant tumor shrinkage in two subjects with large cell and mediastinal B-cell lymphoma. In addition, results showed stable disease for three months or longer in renal, ovarian, non-small cell lung cancer, cholangiocarcinoma and Hodgkin's lymphoma. The study enrolled 10 subjects and was designed to determine the maximum tolerated dose, toxicity profile, pharmacokinetics and pharmacodynamics of intravenous KOS-862. Results were reported at the ECCO 12 European Cancer Conference in Copenhagen.

July 28, 2003

PRIMABioMed Limited reported positive results from a phase Ib trial investigating their Cancer Vac immunotherapy for the treatment of various advanced cancers. Results showed that two subjects who have now continued therapy for 18 months have experienced no progression of their disease. One subject with ovarian cancer showed that their disease marker, which was rising before administration of the immunotherapy, was halted and maintained at a stable level. Tumors in the second subject, with kidney cancer, have also remained stable for over a year. All subjects demonstrated an ability to produce an immune response to the tumor protein. The 12-week study enrolled 12 subjects in Australia. The Cancer Vac therapy involves extracting blood cells, manipulating the immune cells by exposing them to the immunotherapeutic product and then re-injecting these cells to induce a specific immune response.

March 31, 2003

Genzyme Molecular Oncology reported some positive results from 2 phase I/II trials investigating their patient specific dendritic cell vaccine for the treatment of kidney cancer and melanoma. Results from the metastatic kidney cancer study showed that a majority of the subjects achieved immunological responses from the treatment. Four of the thirteen subjects vaccinated achieved stable disease. One subject remained stable for more than seven months following treatment. No serious adverse events were reported and non-serious adverse events were mild. Results from the metastatic melanoma study showed that only a minority of the subjects achieved an immunological response and no subjects achieved a clinical response. No serious adverse events were report and mild events included injection site reactions, muscle twitching, bruising, and skin redness.

January 6, 2003

Isis Pharmaceuticals reported positive results from a phase II trial investigating ISIS 2503 in combination with gemcitabine for the treatment of pancreatic cancer. Results showed 57.5% of subjects who received ISIS 2503, in combination with gemcitabine, survived six months or longer with a median survival time for those 20 subjects of 6.7 months. This was compared to historical gemcitabine pivotal trial results of 46% at six months survival with a median survival time of 5.6 months. The open-label Phase II trial enrolled 48 subjects with locally advanced or metastatic pancreatic cancer who had not received prior chemotherapy for their disease.

Neurocrine Biosciences reported positive results from two trials investigating IL-4 Fusion Toxin (NBI-3001) for the treatment of glioblastoma multiforme and solid tumors. Preliminary data from an ongoing phase I trial conducted in subjects with peripheral solid tumors showed the study has met the primary objectives of defining dose toxicity and tolerance. Two subjects with kidney carcinoma showed stable disease at the maximum tolerated dose. Data from a phase II trial conducted on subjects with glioblastoma multiforme (GBM) showed a median survival greater than six months at low dosage (90 mcg) with the majority of the subjects still alive at time of follow up. MRI scans showed 25% of the subjects reached stable or partial regression of disease. The open label study enrolled 32 subjects with recurrent GBM and infused them intramorally at high, medium and low doses over five days.

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