Less-toxic picoplatin can beat platinum-resistance; safer to treat colorectal, prostate cancers: Poniard

Picoplatin failed to meet a key end-point in non-small cell lung cancer trial

Picoplatin, an investigational drug to treat a range of cancers including colorectal, prostate cancer and  non-small cell lung cancer, is found to be a safer option to existing platinum-based anti-cancer therapies.

Picoplatin is a new and differentiated platinum-based chemotherapeutic agent that is in clinical development for multiple cancer indications, treatment combinations and by two routes of administration.

Picoplatin is designed to overcome platinum resistance associated with chemotherapy in solid tumors.

Study data to date suggest that picoplatin has an improved safety profile relative to existing platinum-based cancer therapies and can be easily combined and safely administered with other currently marketed oncology products.

Approximately 1,100 patients have received picoplatin.  Results obtained to date suggest that hematologic events are common but manageable.

Kidney toxicity (nephrotoxicity) and nerve toxicity (neurotoxicity) are less frequent and less severe than is commonly observed with other platinum chemotherapy drugs.

Picoplatin has demonstrated anti-tumor activity in a variety of solid tumors.

An additional Phase 2 randomized, controlled trial is being conducted with 101 metastatic CRC patients who have not received prior chemotherapy and is comparing the safety, including the incidence and severity of neuropathy, and efficacy, measured by overall survival, progression-free survival and disease control, of intravenous picoplatin in combination with 5-fluorouracil and leucovorin (the FOLPI regimen) to oxaliplatin given in combination with 5-fluorouracil and leucovorin in the modified FOLFOX-6 regimen.

To date the data evaluating picoplatin as a neuropathy-sparing agent compared to oxaliplatin in the first-line treatment of patients with metastatic colorectal cancer (CRC) have shown a statistically significant reduction in neurotoxicities with the use of picoplatin in the FOLPI regimen compared with the use of oxaliplatin in the FOLFOX regimen.

In addition, picoplatin, given once every four weeks in combination with 5-fluorouracil and leucovorin in the FOLPI regimen, and oxaliplatin, given in combination with 5-fluorouracil and leucovorin in the modified FOLFOX-6 regimen, have similar anti-tumor activity as assessed by progression-free survival (PFS) and disease control.

Another Phase 2 study is evaluating the efficacy and safety of picoplatin administered every three weeks in combination with full-dose docetaxel and daily prednisone as a first-line treatment in patients with metastatic castration-resistant prostate cancer (CRPC) who have not received prior chemotherapy.

Prostate-specific antigen (PSA) response (defined as a PSA reduction of at least 50 percent from baseline for 4 weeks) is the primary endpoint of the study.  Secondary endpoints include safety, disease control, time to progression and overall survival.

Date indicate that picoplatin, in combination with docetaxel and prednisone, shows promising efficacy and is well tolerated as first-line therapy for metastatic CRPC.

Efficacy is assessed by several endpoints, including reductions in PSA levels, disease control, and PFS.

Picoplatin can be administered safely every three weeks for up to 10 cycles concurrently with full doses of docetaxel and prednisone which is the current standard first-line treatment for metastatic CRPC.

Picoplatin, which is currently being considered for non-small cell lung cancer as well, failed to meet a key end-point in a Phase 3 trial.

Poniard has completed discussions with the U.S. Food and Drug Administration (FDA) regarding a regulatory path forward for picoplatin in small cell lung cancer (SCLC).

A Phase 3 SPEAR (Study of Picoplatin Efficacy After Relapse) trial enrolled 401 patients and evaluated intravenous picoplatin in SCLC patients who failed or relapsed following first-line platinum therapy within six months following initial treatment with a platinum-based therapy.

While the data analysis showed that the study did not meet the primary endpoint of overall survival, the data suggest a potential trend toward a survival advantage in SCLC patients treated with picoplatin and best supportive care compared to best supportive care alone.

Poniard has evaluated intravenous picoplatin in the treatment of SCLC in its Phase 3 SPEAR trial.

This trial did not meet its primary endpoint of overall survival, and the Company plans to meet with the FDA to discuss a potential regulatory path forward for picoplatin in this indication.

Poniard Pharmaceuticals, Inc. is a biopharmaceutical company.