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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 currently in Phase 3 clinical development and is not yet approved by regulatory authorities. The drug is being evaluated in patients who have received prior second-line hormonal treatment.
PNT2002 targets PSMA, or prostate-specific membrane antigen, a protein highly expressed on prostate cancer cells. As a radiolabeled small molecule, it is designed to deliver radiation directly to PSMA-expressing tumor cells. This targeted approach is being investigated in patients with metastatic castration-resistant prostate cancer.
PNT2002 is being developed by Eli Lilly and Company, a pharmaceutical company listed on the New York Stock Exchange under the ticker symbol LLY. The drug is currently in Phase 3 clinical trials for metastatic castration-resistant prostate cancer.
PNT2002 is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The ongoing Phase 3 trial is actively enrolling participants, though recruitment is complete, and the study is no longer accepting new patients.
PNT2002 is being evaluated in a single Phase 3 clinical trial registered as NCT04647526. This randomized, active-controlled study is investigating the drug in 455 male patients with metastatic castration-resistant prostate cancer who have received prior second-line hormonal treatment. The trial is being conducted in the United States, Canada, France, Netherlands, Sweden, and the United Kingdom.
Yes, PNT2002 is also known as [Lu-177]-PNT2002. The drug is a lutetium-177 radiolabeled compound, and the alternative name reflects its radioactive isotope component. Both names refer to the same investigational therapy being developed for metastatic castration-resistant prostate cancer.