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Also known as [Lu-177]-PNT2002
PNT2002 · 1 trial · 1 indication
* rPFS, as assessed by blinded independent central review (BICR), is the time from the randomization date to progression on soft tissue per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) or confirmed progression on bone lesions by Prostate Cancer Working Group 3 (PCWG3) criteria, or death from any cause. * The date of disease progression is the date of the scan for the first objectively documented progressive disease (PD) per RECIST v1.1 or PCWG3. PD is defined as a ≥20% increase in the sum of the diameters of target lesions (≥5 mm absolute), with reference being the smallest sum in the study, or unequivocal progression of non-target lesions, or appearance of new lesions. * Participants who do not progress, including those who started new anticancer therapy, withdrew from the study, or were lost to follow-up without disease progression, were censored at the last valid assessment for RECIST v1.1 or PCWG3.
| Arm | Type | Description |
|---|---|---|
| Lead-in Dosimetry Phase: [Lu-177]-PNT2002 | EXPERIMENTAL | Participants received 6.8 gigabecquerels (GBq) (±10%) of \[Lu-177\]-PNT2002 by intravenous infusion every 8 weeks for 4 cycles. |
| Randomization Phase: [Lu-177]-PNT2002 (Arm A) | EXPERIMENTAL | Participants received 6.8 GBq (±10%) of \[Lu-177\]-PNT2002 by intravenous infusion every 8 weeks for 4 cycles. |
| Randomization Phase: Abiraterone or Enzalutamide (Arm B) | ACTIVE_COMPARATOR | Participants received either of below treatments until radiographic progression. * Enzalutamide 160 milligram (mg) orally once daily (or) * Abiraterone 1000 mg orally once daily coadministered with prednisone 5 mg orally twice daily or dexamethasone 0.5 mg orally once daily. Participants who experienced radiographic progression per Blinded Independent Central Review (BICR) (or after final overall survival (OS), per local investigator-assessment), had not started an intervening treatment, and had no uncontrolled adverse events (AEs) were eligible to consent to cross over to receive 6.8 GBq (±10%) of \[Lu-177\]-PNT2002 intravenous infusion every 8 weeks for 4 cycles. |
| Pharmacokinetic (PK) Extension Phase: [Lu-177]-PNT2002 | EXPERIMENTAL | Participants received 6.8 GBq (±10%) of \[Lu-177\]-PNT2002 by intravenous infusion every 8 weeks for 4 cycles. |
| Name | Type | Description |
|---|---|---|
| [Lu-177]-PNT2002 | DRUG | Participants randomized to Arm A will receive 6.8 GBq (±10%) of \[Lu-177\]-PNT2002 every 8 weeks for 4 cycles |
| Abiraterone | DRUG | Abiraterone (1000 mg orally once daily with: 5 mg twice daily prednisone or 0.5 mg once daily dexamethasone) |
| Enzalutamide | DRUG | Enzalutamide (160 mg orally once daily) |
Inclusion Criteria: 1. Male aged 18 years or older. 2. Histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate. 3. Ineligible or averse to chemotherapeutic treatment options. 4. Patients must have progressive mCRPC at the time of consent based on at least 1 of ...
PNT2002 is an investigational small molecule being studied for the treatment of metastatic castration-resistant prostate cancer (mCRPC). It is a radioligand therapy that delivers a radioactive isotope, lutetium-177, to prostate-specific membrane antigen (PSMA)-expressing cells. The drug is currently in Phase 3 clinical development.
PNT2002 targets PSMA, or prostate-specific membrane antigen, a protein that is highly expressed on prostate cancer cells. By binding to PSMA, the drug delivers a radioactive payload directly to the tumor cells, potentially causing damage to the cancer while sparing normal tissue. This mechanism is being evaluated in patients with metastatic castration-resistant prostate cancer.
PNT2002 is being developed by Eli Lilly and Company, a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol LLY. The company is conducting a Phase 3 clinical trial to evaluate the drug in patients with metastatic castration-resistant prostate cancer.
PNT2002 is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The ongoing Phase 3 trial is designed to assess the safety and efficacy of PNT2002 in patients with metastatic castration-resistant prostate cancer who have received prior hormonal treatment.
PNT2002 is being evaluated in a single Phase 3 clinical trial with the identifier NCT04647526. This active, non-recruiting study is titled 'Study Evaluating mCRPC Treatment Using PSMA [Lu-177]-PNT2002 Therapy After Second-line Hormonal Treatment.' It enrolls 455 male patients aged 18 years and older with metastatic castration-resistant prostate cancer across the United States, Canada, France, Netherlands, Sweden, and the United Kingdom.
Yes, PNT2002 is also known as [Lu-177]-PNT2002. The name indicates that the drug is a conjugate of the radioactive isotope lutetium-177 with the targeting molecule PNT2002. This alternative name is used in clinical trial documentation to specify the radiolabeled form of the drug being studied.