肿瘤疫苗是利用患者自身的肿瘤细胞、肿瘤特异性抗原及其它免疫调节细胞来治疗和预防肿瘤，它开辟了一条安全有效治疗肿瘤的现代途径。
Corixa公司和AVAX技术公司治疗黑素瘤的Melacine和M-Vax癌症疫苗分别已在加拿大和澳大利亚上市；Intracel Holdings公司以异源技术平台开发的世界上首个全人源抗体HumaSPECT癌症疫苗已在欧盟获准上市，其并驾齐驱的OncoVAX癌症疫苗已在荷兰销售。新近获准上市的肿瘤疫苗有脑癌疫苗、肾癌疫苗和宫颈癌疫苗等。目前全世界有20多个癌症疫苗正在进行各种肿瘤适应证的Ⅲ期临床研究，获准上市的产品也将不断增多。

肾癌疫苗 
肾癌疫苗维特斯朋（vitespen）是美国Antigenics公司已在俄罗斯获准上市的产品（商品名：Oncophage），用于治疗中间复发危险的肾癌患者。 
本品代表了治疗中间复发危险的肾癌患者的重大进步。它是在全球批准的第一个个体化肾癌疫苗。目前，对非转移性肾癌的常规治疗方法是切除患肾，随后观察。手术后这些患者常需预防或延缓癌症的复发。肾癌疫苗维特斯朋获准上市意味着在肾癌的早期阶段就可使用本品治疗。
本品获准上市是基于大型随机肾癌辅助治疗的Ⅲ期临床研究结果。在此研究中，随机在全世界118个研究中心以604例已切除肾癌的患者（包括俄罗斯8地172例）为基础，主要疗效数据支持了此应用。 
研究结果显示，接受Oncophage治疗中间复发危险（Ⅰ/Ⅱ高危阶段，ⅢT1/2低危阶段）的切除肾癌患者（n=362），45％以上在临床上显著改善无复发存活率（P<0.01;风险比=0.55）。虽然，改善者尚未达到一半，但其中25％无复发存活期延长约1.7年。

Oncophage® patient-specific cancer vaccine

What is Oncophage?

In April 2008, Oncophage^® (vitespen; formerly HSPPC-96) was approved in Russia for the adjuvant treatment of kidney cancer patients at intermediate-risk for disease recurrence. Pre-commercial launch activities are ongoing. In October 2008, Antigenics submitted a marketing authorization application to the European Medicines Agency (EMEA) requesting conditional approval for Oncophage in earlier-stage, localized renal cell carcinoma. The company expects a decision from the EMEA around the end of 2009.

Outside Russia, Oncophage is an investigational patient-specific vaccine designed to treat cancer with the intent of minimizing side effects. Currently being evaluated in clinical trials, treatment with Oncophage is designed to target only cancerous cells — not healthy normal cells. As a result, Oncophage is designed to limit the toxicities associated with traditional broad-acting cancer treatments.

Oncophage received fast track and orphan drug designations from the US Food and Drug Administration (FDA) for both kidney cancer and metastatic melanoma as well as orphan drug designation from the EMEA for kidney cancer. In 2009, Oncophage also received orphan drug designations from the FDA and EMEA for glioma.

In April 2009, the World Vaccine Congress named Oncophage as the best therapeutic vaccine.

How does Oncophage work?

Based on proprietary heat shock protein technology, the Oncophage vaccine is designed to capture the particular cancer’s ‘fingerprint.’ This fingerprint contains unique antigens (substances that can provoke an immune response) that are present only on that particular patient’s specific cancer cells. Injection of the vaccine is intended to stimulate the patient’s immune system to recognize and attack any cells bearing the specific cancer fingerprint. (animation)

 Learn more about heat shock proteins and HSP technology.

How is Oncophage made?

Oncophage is a vaccine made from individual patients’ tumors. Patients have surgery to remove part or all of the cancerous tissue, and the tumor tissue is shipped overnight to Antigenics’ manufacturing facility in Massachusetts.

Using a proprietary manufacturing process, the heat shock protein gp96 and its associated peptides are isolated from the tumor. The complexes are extracted and purified from each sample, then sterilely filtered and placed into vials. The final product is subject to extensive quality-control testing, including sterility testing of each lot. The vaccine is shipped frozen back to the hospital pharmacy for use when the patient has recovered from surgery.

 What’s the difference between Oncophage and other treatments?

Oncophage is different because it’s:

• A vaccine that may help your immune system fight your cancer
• Patient-specific — it’s created from cells from your own body
• A therapy designed to target specific tumor cells only, thereby leaving healthy cells alone

What is treatment with Oncophage like?

Should Oncophage be successfully prepared from a patient’s tumor, the patient receives the vaccine usually within four to eight weeks after surgery (once the patient has recovered from surgery). The patient receives one injection of Oncophage vaccine once a week for four weeks, then one Oncophage injection every other week. Oncophage treatment is designed to be given on an outpatient basis.

How many people have received Oncophage therapy?

Aprroximately 800 cancer patients in more than a dozen clinical trials around the world have received Oncophage in clinical trials. Many of these patients had advanced disease, including kidney cancer, melanoma and colon cancer, and had not responded to traditional cancer treatments.

 Find out more about results of past clinical trials.

What are the side effects of Oncophage treatment?

To date, the most common side effects reported in clinical studies with Oncophage were injection-site reactions, pain (in extremities, back, chest, abdomen), nausea, constipation, fatigue, fever, diarrhea, edema (organ/tissue swelling due to excess fluids), weight loss, nasopharyngitis (cold symptoms), arthralgia (pain in the joints), dizziness, anxiety, depression, cough, dyspnea (difficulty breathing), headache, vomiting, anemia, insomnia (difficulty sleeping), anorexia (loss of appetite) and asthenia (weakness).

In what kind of cancers is Oncophage being tested?

The Brain Tumor Research Center at the University of California, San Francisco, is currently evaluating Oncophage in an investigator-sponsored, Phase 1/2 study as a treatment for recurrent glioma. The primary goal of the study is to establish the feasibility, safety and preliminary efficacy of Oncophage vaccination in glioma patients. Learn more about this trial.

Oncophage has also been evaluated in two international Phase 3 trials in kidney cancer and metastatic melanoma, as well as studies in several other cancers, such as non-small cell lung cancer, lymphoma, colorectal cancer, pancreatic cancer and gastric cancer. Antigenics also plans to investigate Oncophage in clinical trials in combination with other therapies

What are the results from clinical trials of Oncophage?

In 2007, results from Antigenics’ Phase 3 trial of Oncophage in kidney cancer showed a 45-percent improvement in recurrence-free survival associated with Oncophage in patients with intermediate-risk kidney cancer (n=362), although a significant improvement was not observed in the overall patient population (n=604). In 2009, interim survival data showed that Oncophage appeared to lower the risk of death by almost 46 percent in the intermediate-risk population. Final results are expected in 2010.

In a Phase 3 study of Oncophage in metastatic melanoma, overall median survival was 29 percent longer in patients who received at least 10 injections of Oncophage compared with physician’s choice regimen.

Final results from an investigator-sponsored, Phase 1/2 study evaluating Oncophage as a treatment for recurrent glioma, being conducted at the University of California, San Francisco, showed that Oncophage vaccination increased overall median survival to approximately 10.5 months with four patients surviving beyond 12 months and one patient surviving almost 2.5 years. This is compared to a historical median survival of only 6.5 months post surgery. All patients enrolled into the trial had at least one recurrence of brain cancer.

A Phase 2 glioma study is expected to complete enrollment by late 2009 and data will be submitted for publication and presentation in early 2010.