On May 12, 2025 Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), the Breast International Group (BIG), Institut Jules Bordet Clinical Trials Support Unit and Frontier Science Foundation, reported statistically significant final overall survival (OS) results from the Phase III APHINITY study in people with human epidermal growth factor receptor 2 (HER2)-positive early-stage breast cancer (Press release, Genentech, MAY 12, 2025, View Source [SID1234652892]). After ten years, the risk of death was reduced by 17% for people treated with Perjeta (pertuzumab), Herceptin (trastuzumab) and chemotherapy (the Perjeta-based regimen) for a year as post-surgery (adjuvant) treatment, compared with individuals who received Herceptin, chemotherapy, and placebo.
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"Early treatment of breast cancer can provide substantial patient benefit and also increases the chance for cure. For people with early-stage HER2-positive disease, the APHINITY results validate the sustained benefits of the Perjeta-based regimen," said Levi Garraway, M.D., Ph.D., Genentech’s chief medical officer and head of Global Product Development. "These long-term data reinforce the regimen’s value as a well-established standard-of-care treatment in the curative setting."
"After ten years, the APHINITY trial clearly shows a statistically significant and clinically meaningful improvement of the overall survival," said Prof. Sibylle Loibl, APHINITY study chair, chair of the German Breast Group (GBG) and the chief executive officer of the GBG Forschungs GmbH. "Adding Perjeta to a standard adjuvant treatment is most beneficial for people with HER2-positive breast cancer with lymph node-positive disease who are at high risk of recurrence."
After ten years, results show:
91.6% of people treated with the Perjeta-based regimen were alive at ten years versus 89.8% of those treated with Herceptin, chemotherapy, and placebo (hazard ratio [HR]=0.83, 95% CI: 0.69-1.00, p-value=0.044).
A 21% reduction in the risk of death was seen in the prespecified subgroup of people with lymph node-positive disease (HR=0.79, 95% CI: 0.64-0.97).
The previously reported invasive disease-free survival (primary endpoint) benefit was maintained (HR=0.79, 95% CI: 0.68-0.92), strengthening results from earlier APHINITY analyses. No benefit was seen in the node negative subgroup.
The safety profile, including cardiac safety, was consistent with previous studies and no new or unexpected safety signals were identified.
Full results will be presented as a late-breaking abstract on Thursday, May 15 at the 2025 European Society for Medical Oncology Breast Cancer Congress.
"The international collaborations in APHINITY have facilitated important insights about HER2-positive breast cancer and are continuing to yield promising findings," said Liz Frank, independent research advocate. "Scientists and clinicians are working together with the broader goal of improving our understanding of HER2-positive breast cancer, improving the quality of life for people living with the disease and ultimately, helping them to live longer with no disease occurring."
The collaborative efforts of Genentech, BIG, and study partners enabled the initiation of pivotal trials such as APHINITY and HERA. These studies led to Herceptin and Perjeta becoming standards of care and helped improve outcomes for people with early-stage HER2-positive breast cancer.
About the APHINITY study
APHINITY (Adjuvant Pertuzumab and Herceptin IN Initial TherapY in Breast Cancer, NCT01358877/ BO25126/ BIG 4-11) is a global, Phase III, randomized, double-blind, placebo-controlled, two-arm study evaluating the efficacy and safety of Perjeta (pertuzumab) plus Herceptin (trastuzumab) and chemotherapy, compared with Herceptin and chemotherapy, as post-surgery (adjuvant) treatment in 4,804 people with operable human epidermal growth factor receptor 2-positive early-stage breast cancer.
The primary endpoint is invasive disease-free survival, which in this study is defined as the time a patient lives without recurrence of invasive breast cancer (when the cancer returns locally or spreads into the surrounding breast tissue and/or beyond) or death from any cause after post-surgery treatment. Secondary endpoints include cardiac and overall safety, overall survival and health-related quality of life.
What is Perjeta?
Perjeta (pertuzumab) is a prescription medicine approved for use in combination with Herceptin and chemotherapy for:
Use prior to surgery (neoadjuvant treatment) in adults with HER2-positive, locally advanced, inflammatory, or early stage breast cancer as part of a complete treatment regimen for early breast cancer
Use after surgery (adjuvant treatment) in adults with HER2-positive early breast cancer that has a high likelihood of coming back
Perjeta (pertuzumab) is a prescription medicine approved for use in combination with Herceptin and docetaxel in adults who have HER2-positive breast cancer that has spread to different parts of the body (metastatic) and who have not received prior anti-HER2 therapy or chemotherapy for metastatic breast cancer.
Important Safety Information
What are the possible side effects of Perjeta?
Perjeta may cause serious side effects, including:
Perjeta can cause heart problems, including those without symptoms (such as reduced heart function) and those with symptoms (such as congestive heart failure)
Your doctor will run tests to monitor your heart function before and during treatment
Based on these tests, your treatment may be interrupted or discontinued
Contact a health care professional immediately if you experience any of the following: new onset or worsening shortness of breath, cough, swelling of the ankles/legs, swelling of the face, palpitations, weight gain of more than 5 pounds in 24 hours, dizziness or loss of consciousness
Receiving Perjeta during pregnancy can result in the death of an unborn baby and birth defects.
Your doctor will verify your pregnancy status before treatment begins
Birth control should be used while receiving Perjeta and for 7 months after your last dose of Perjeta. If you are a mother who is breastfeeding, you should talk with your doctor about either stopping breastfeeding or stopping Perjeta
If you think you may be pregnant, you should contact your healthcare provider immediately
If you are exposed to Perjeta during pregnancy, or become pregnant while receiving Perjeta or within 7 months following the last dose of Perjeta with Herceptin, you are encouraged to report Perjeta exposure to Genentech at 1-888-835-2555
Who should not take Perjeta?
Perjeta should not be used in patients who are allergic to pertuzumab or to any of the ingredients in Perjeta.
What are other possible serious side effects of Perjeta?
Serious side effects of Perjeta may also include:
Infusion-related reactions: Perjeta is given as an infusion. Perjeta can cause serious infusion-related reactions, some fatal. When given alone, the most common infusion-related reactions were fever, chills, fatigue, headache, weakness, hypersensitivity, and vomiting. When given with Herceptin and docetaxel, the most common infusion-related reactions were fatigue, altered taste, hypersensitivity, muscle pain, and vomiting
Severe allergic reactions: Perjeta can cause hypersensitivity reactions, including anaphylaxis and fatal events. Contact a health care professional immediately if you experience any of the following symptoms: swelling of the face, lips or tongue, trouble breathing, or chest pains
The most common side effects of Perjeta include:
The most common side effects of Perjeta when given with Herceptin and chemotherapy prior to surgery for early breast cancer include:
Constipation
Damage to the nerves (numbness, tingling, pain in hands/feet)
Diarrhea
Fatigue
Hair loss
Headache
Decreased red blood cell counts, white blood cell counts, and platelet counts
Mouth sores or blisters
Nausea
Muscle pain
Vomiting
Weakness
The most common side effects of Perjeta when given with Herceptin and chemotherapy after surgery for early breast cancer include:
Diarrhea
Nausea
Hair loss
Fatigue
Damage to the nerves (numbness, tingling, pain in hands/feet)
Vomiting
The most common side effects of Perjeta when given with Herceptin and docetaxel for metastatic breast cancer include:
Diarrhea
Hair loss
Low levels of white blood cells with or without fever
Nausea
Fatigue
Rash
Damage to the nerves (numbness, tingling, pain in hands/feet)
Side effects may vary based on chemotherapy regimen. These are not all the possible side effects of Perjeta. Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or View Source You may also report side effects to Genentech at 1-877-436-3683.
Before you take Perjeta, tell your healthcare provider about all of your medical conditions, including if you:
Have a history of heart disease
Are pregnant or plan to become pregnant. Perjeta can harm your unborn baby
Are breastfeeding or plan to breastfeed. It is not known if Perjeta passes into your breastmilk
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Please see the full Prescribing Information for additional Important Safety Information, including most serious side effects.
What is Herceptin?
Herceptin is approved for the treatment of early stage breast cancer that is Human Epidermal growth factor Receptor 2-positive (HER2-positive) and has spread into the lymph nodes, or is HER2-positive and has not spread into the lymph nodes. If it has not spread into the lymph nodes, the cancer needs to be estrogen receptor/progesterone receptor (ER/PR)-negative or have one high-risk feature.* Herceptin can be used in several different ways:
As part of a treatment course including the chemotherapy drugs doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel. This treatment course is known as "AC→ TH."
With the chemotherapy drugs docetaxel and carboplatin. This treatment course is known as "TCH."
Alone after treatment with multiple other therapies, including an anthracycline (doxorubicin)-based therapy (a type of chemotherapy).
Patients are selected for therapy based on an FDA-approved test for Herceptin.
*High risk is defined as ER/PR-positive with one of the following features: tumor size greater than 2 cm, age less than 35 years, or tumor grade 2 or 3.
Important Safety Information
Possible serious side effects with Herceptin
Not all people have serious side effects, but side effects with Herceptin therapy are common.
Although some people may have a life-threatening side effect, most do not.
A patient’s doctor will stop treatment if any serious side effects occur.
Herceptin is not for everyone. A patient should be sure to contact their doctor if they are experiencing any of the following:
HEART PROBLEMS
These include heart problems—such as congestive heart failure or reduced heart function—with or without symptoms. The risk for and seriousness of these heart problems were highest in people who received both Herceptin and a certain type of chemotherapy (anthracycline). In a study of adjuvant (early) breast cancer, one patient died of significantly weakened heart muscle. A patient’s doctor will check for signs of heart problems before, during, and after treatment with Herceptin.
INFUSION REACTIONS, including:
Fever and chills
Feeling sick to your stomach (nausea)
Throwing up (vomiting)
Pain (in some cases at tumor sites)
Headache
Dizziness
Shortness of breath
These signs usually happen within 24 hours after receiving Herceptin.
A patient should be sure to contact their doctor if they:
Are a woman who could become pregnant, or may be pregnant
Herceptin may result in the death of an unborn baby or birth defects. Contraception should be used while receiving Herceptin and for 7 months after your last dose of Herceptin. If you are or become pregnant while receiving Herceptin or within 7 months after your last dose of Herceptin, you should immediately report HERCEPTIN exposure to Genentech at 1-888-835-2555.
Have any signs of SEVERE LUNG PROBLEMS, including:
Severe shortness of breath
Fluid in or around the lungs
Weakening of the valve between the heart and the lungs
Not enough oxygen in the body
Swelling of the lungs
Scarring of the lungs
A patient’s doctor may check for signs of severe lung problems when he or she examines the patient.
Have LOW WHITE BLOOD CELL COUNTS
Low white blood cell counts can be life threatening. Low white blood cell counts were seen more often in patients receiving Herceptin plus chemotherapy than in patients receiving chemotherapy alone.
A patient’s doctor may check for signs of low white blood cell counts when he or she examines the patient.
Side effects seen most often with Herceptin
Some patients receiving Herceptin for breast cancer had the following side effects:
Fever
Feeling sick to your stomach (nausea)
Throwing up (vomiting)
Infusion reactions
Diarrhea
Infections
Increased cough
Headache
Feeling tired
Shortness of breath
Rash
Low white and red blood cell counts
Muscle pain
A patient should contact their doctor immediately if they have any of the side effects listed above.
Patients are encouraged to report side effects to Genentech and the FDA. You may report side effects to FDA at 1-800-FDA-1088 or View Source You may also report side effects to Genentech at 1-877-436-3683.
Please see the full Prescribing Information, including Boxed WARNINGS and additional Important Safety Information, at View Source