Oncophage® Personalized Cancer Vaccine

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Glossary

WHAT IS ONCOPHAGE?

Oncophage® (vitespen; formerly HSPPC-96) is an investigational personalized vaccine designed to treat cancer with the intent of minimizing side effects. Oncophage is currently being investigated as a cancer treatment and is only administered to patients in research studies.

The US Food and Drug Administration has designated Oncophage a fast track product for evaluation in the treatment of kidney cancer. Products are designated as fast track when they are intended to treat a serious medical condition and have the potential to address an unmet medical need.

HOW DOES ONCOPHAGE WORK?

Oncophage is a therapeutic vaccine made from individual patients’ tumors. Once patients have had surgery to remove the kidney cancer, a portion of the tumor is sent to Antigenics (the company that makes Oncophage) so that the tumor-derived vaccine can be made.

Vaccines provoke the body’s natural disease-fighting response. A vaccine that is made from the patient’s own tumor is designed to contain the particular cancer’s ‘fingerprint.’ Injection of the Oncophage vaccine may cause the body to attack any cells bearing this cancer ‘fingerprint.’

WHAT’S THE DIFFERENCE BETWEEN ONCOPHAGE AND OTHER TREATMENTS?

Oncophage is different because it’s:

  • A vaccine that may help to ‘immunize’ you from getting kidney cancer again
  • Personalized—it’s created from cells from your own body
  • A therapy designed to target specific tumor cells only, thereby leaving healthy cells alone.

WHY IS ONCOPHAGE BEING STUDIED?

Oncophage is being studied because encouraging results have been seen in more than a dozen clinical trials worldwide, involving more than 700 patients. These findings are now being validated in large Phase 3 studies.

HOW MANY PEOPLE HAVE RECEIVED ONCOPHAGE THERAPY?

More than 700 cancer patients around the world have received Oncophage in clinical trials.

WHAT ARE THE SIDE EFFECTS OF ONCOPHAGE TREATMENT?

In clinical trials to date, reported adverse events (side effects) have been minimal.

WHAT WILL THIS STUDY BE TESTING?

The Phase 3 study will be comparing the current standard of care for kidney cancer with the current standard of care plus treatment with Oncophage. The current standard of care is nephrectomy (surgery to remove all or part of the kidney), followed by observation (regular visits to the doctor to check if the cancer has come back). That means that this study will compare surgery alone versus surgery plus Oncophage.

STUDY OF ONCOPHAGE IN KIDNEY CANCER
(PROTOCOL C-100-12)
WHO
will be tested?		 More than 700 kidney cancer patients who are scheduled to have nephrectomies
WHERE
will the study take place?		 At medical institutions all over the world
WHAT
will the study be testing?		 Nephrectomy vs.
Nephrectomy + Oncophage
WHY
is the study being done?		 To see if Nephrectomy + Oncophage is better than Nephrectomy alone at:
  • Prolonging survival
  • Preventing the cancer from coming back

AM I ELIGIBLE FOR THIS RESEARCH STUDY WITH ONCOPHAGE?

Only your doctor can help to determine if this study is right for you. Good candidates for the study are kidney cancer patients who plan to have nephrectomies and who have never received any sort of therapy for their kidney cancer.

IF I ENROLL IN THE STUDY, WILL I DEFINITELY RECEIVE ONCOPHAGE?

After surgery, patients enrolled in the study will be randomized (assigned by chance) to receive either surgery alone (the current standard of care) or surgery plus treatment with Oncophage. If you are enrolled in the study, there is a 50 percent chance that you will receive Oncophage.





WHAT IS TREATMENT WITH ONCOPHAGE LIKE?

After your nephrectomy, your tumor is sent to Antigenics for processing, and an attempt is made to manufacture Oncophage from your tumor. Should Oncophage be successfully prepared, you will receive the vaccine usually within four to eight weeks after your surgery, once you have recovered from surgery. You receive one shot of your personalized Oncophage vaccine once a week for four weeks, then one Oncophage shot every other week. Oncophage treatment is designed to be given on an outpatient basis.

WILL USING ONCOPHAGE GUARANTEE THAT MY CANCER WON’T RETURN?

Using Oncophage is not a guarantee that your cancer will not return.

WILL MY INSURANCE COVER THE COST OF PARTICIPATING IN THE STUDY?

While you are participating in the research study, any procedures that are required by the study protocol will either be covered by your insurance (as part of your usual medical care) or by Antigenics (the company that makes Oncophage). Talk with your doctor for more details.

HOW DO I ENROLL IN THE STUDY?

Part 1 of this trial is closed to enrollment. For information on Part 2 of the trial, please call 866.805.8994 (toll-free), or e-mail Antigenics Clinical Affairs.