Update: New drug approved for metastatic prostate cancer
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UPDATE AT A GLANCE
What is this update about?
This update is about approval of the drug Pluvicto for treating people with castration-resistant cancer (mCRPC). The also approved a drug called Locametz that can be used with imaging to identify patients who will likely benefit from treatment with Pluvicto.
Why is this update important?
castration-resistant cancer remains incurable, although many types of drugs delay progression and prolong life.
Pluvicto (177Lu-PSMA-617) is a drug that delivers radiation directly to tumor cells that express a protein known as PSMA. PSMA (also known as ) is found at low levels in normal cells but it is found at high levels in some cancer cells. Pluvicto works on tumor cells that have increased PSMA.
The also approved Locametz (Ga 68 PSMA-11) to detect PSMA levels in cancer cells that have spread throughout the body. For more information on the approval of this imaging drug, read our XRAY review here. Imaging with Locametz can determine if a person’s cancer is likely to respond to Pluvicto.
The approval was based on the results of the VISION trial. VISION compared patients who were treated with Pluvicto and protocol-permitted standard care or protocol-permitted standard care alone. Standard-care therapy that was permitted included approved hormonal treatments (including abiraterone and enzalutamide), bisphosphonates, radiation therapy, denosumab, or glucocorticoid at any dose. Standard-care excluded chemotherapy, , radium-223 (223Ra), and investigational drugs. All the participants had prior treatment with an androgen receptor pathway inhibitor and chemotherapy and had tumors that expressed high levels of PSMA. High levels of PSMA were defined as at least one PSMA-positive lesion and no PSMA-negative lesions. PSMA-positive status was determined with the use of -68 (68Ga)–labeled PSMA-11 (68Ga-PSMA-11) PET–CT imaging.
Patients treated with Pluvicto had significantly improved overall and progression-free survival. Among patients treated with Pluvicto plus standard of care:
- Overall survival was 15.3 months compared to 11.3 months for patients treated with standard of care alone.
- Progression-free survival was 8.7 months compared to 3.4 months for patients treated with standard of care alone.
Almost 57 percent of participants who were treated with Pluvicto had an of grade 3 or higher compared to 38 percent of participants who were treated with standard of care alone. Garde 3 adverse events were defined as severe or medically significant but not immediately life-threatening. The most common adverse events were:
- Dry mouth
- Decreased appetite
However, participants who were treated with Pluvicto did not report that their quality of life was adversely affected.
Strengths and limitations
- The VISION trial included almost 600 participants.
- The imaging criteria that was used in this trial allowed patients with PSMA-positive castration-resistant cancer to receive life-extending therapy on the basis of only one plus conventional imaging.
- Adverse events were defined as occurring during the treatment period for up to 30 days after the last dose of Pluvicto or standard-of-care treatment. The 30-day post-dose period for such adverse events may have led to underestimating adverse events.
- Most (87%) of enrolled patients were white.
- The study was not blinded or controlled so many patients left the study if they didn’t get Pluvicto.
What does this mean for me?
In most patients with mCRPC, lesions are positive for PSMA. Treatments like Pluvicto are begin developed to target cancer cells while sparing healthy cells.
If you have been diagnosed with mCRPC and have previously been treated with and androgen receptoro pathway inhibitor and chemotherapy, then you may be eligible for additional imaging with Locametz to see if you would benefit from treatment with Pluvicto.
approves Pluvicto for castration-resistant cancer. www.fda.gov, March 23, 2022.
Sartor O, de Bono J, Chi KN, Fizazi K, et al. Lutetium-177-PSMA-617 for Castration-Resistant Cancer. N Engl J Med. 2021 Sep 16;385(12):1091-1103. Epub 2021 Jun 23.
Disclosure: FORCE receives funding from industry sponsors, including companies that manufacture cancer drugs, tests and devices. All XRAYS articles are written independently of any sponsor and are reviewed by members of our Scientific Advisory Board before publication to assure scientific integrity.
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This article is relevant for:
People who have been diagnosed with metastatic prostate cancer.
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People with prostate cancer
People with metastatic or advanced cancer
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- Am I a candidate for PSMA imaging?
- Am I a candidate for PSMA-targeted therapy?
- Am I a candidate for other therapies for mCRPC, such as a ?
- Should I have genetic testing?
- Should I have tumor testing?
The following studies are looking at PARP inhibitors and similar agents for treating people with advanced cancer.
- NCT04592237: Chemotherapy, and for the Treatment of Aggressive Variant Cancer. This study will look at how well the combination of chemotherapy drugs (such as cabazitaxel and carboplatin), a PARP inhibitors (), and an agents (cetrelimab) works for treating people with a rare type of cancer known as aggressive variant cancer (AVPC).
- NCT04821622: TALAPRO-3: A Clinical Trial in Men with Castration-Sensitive Cancer (mCSPC) and Damage Repair (DDR) Gene Alterations. TALAPRO-3 is a trial for men who have been diagnosed with castration-sensitive cancer (mCSPC) which means that the tumor has spread to other parts of the body but it is still sensitive to hormone therapies.
- NCT05005728: XmAb®20717 Alone or in Combination With Chemotherapy or in Patients With Castration-Resistant Cancer. This study will look at the safety and clinical activity of the drug XmAb20717 alone or in combination with standard-of-care anticancer therapies in patients with castration-resistant cancer who have been treated with at least 2 prior lines of treatment.
- NCT04455750: A Clinical Study Evaluating The Benefit of Adding to Enzalutamide for Men With Prostate Cancer That Has Become Resistant To Testosterone-Deprivation Therapy. This trial is evaluating the benefit of and enzalutamide combination therapy versus enzalutamide alone for the treatment of men with prostate cancer that has become resistant to testosterone-deprivation therapy.
- NCT03317392: Studying the Medication Olaparib Given with Radium-223 for Advanced Cancer with Bone . This study is measuring the best dosage for and side effects of the drug combination olaparib and radium-223 to treat men with mCRPC that has spread to the bones.
- NCT04497844: Treatment for Castration-Sensitive Cancer and Inherited or Tumor Mutations in Damage Repair Genes (Amplitude). The goal of AMPLITUDE is to see if adding to standard of care hormone therapy (ADT) is safe and more effective than standard of care alone. The study is enrolling people who have castration-sensitive cancer and have an inherited or tumor mutation in one of the following genes involved in damage repair: , , , , FANCA,PALB2, RAD51B and RAD54L.
Other clinical trials for people with cancer can be found here.
The following studies are looking at treatment for prostate cancer using PSMA-targeted therapies.
- NCT05204927: Lu-177-PSMA-I&T for Castration-Resistant Cancer. This study will compare Lutetium 177Lu-PSMA-I&T to standard-of-care hormone therapy as treatment for men with castration-resistant cancer.
- NCT03724747: Study to Evaluate the Safety, Tolerability,Pharmacokinetics, and Antitumor Activity of a Thorium-227 Labeled Antibody-chelator Conjugate Alone and in Combination With Darolutamide, in Patients With Castration Resistant Cancer. This study is looking at the safety and dosage of the investigational drug (BAY 2315497 Injection) which targets cancers expressing (PSMA). BAY2315497 Injection will be given alone, or in combination with darolutamide.
- NCT04647526: Study Evaluating mCRPC Treatment Using PSMA [Lu-177]-PNT2002 Therapy After Second-line Hormonal Treatment (SPLASH). The purpose of this study is to evaluate the efficacy and safety of [Lu-177]-PNT2002 in patients with castration-resistant cancer who have progressed after treatment with androgen receptor axis-targeted therapy (ARAT).
- NCT04249947: P-PSMA-101 CAR-T Cells in the Treatment of Subjects With Castration-Resistant Cancer (mCRPC) and Advanced Salivary Gland Cancers (SGC). This study is looking at treatment using a type of known as CAR-T for treating prostate cancer that expresses PSMA.
Other clinical trials for people with cancer can be found here.
The following organizations offer peer support services for people with or at high risk for cancer:
- FORCE peer support
- Visit our message boards.
- Once you register, you can post on the Diagnosed With Cancer board to connect with other people who have been diagnosed.
- Sign up for our Peer Navigation Program.
- Users are matched with a volunteer who shares their mutation and situation.
- Join our private Facebook group.
- Find a virtual or in-person support meeting.
- Join a Zoom community group meeting.
- Visit our message boards.
- ZERO-The End of Cancer is a nonprofit organization that provides information and support resources for men with cancer.