The Use of Lurbinectedin for the Treatment of Small Cell and Neuroendocrine Carcinoma of the Prostate.

Lurbinectedin is FDA approved for treatment of metastatic small cell lung cancer (SCLC) following progression on or after platinum-based chemotherapy. Prostatic small cell or neuroendocrine carcinoma (SC/NEPC) behaves like SCLC; however, no safety or efficacy data for lurbinectedin in SC/NEPC exists. All SC/NEPC patients treated with lurbinectedin across 4 academic oncology centers were identified. Baseline patient data and lurbinectedin outcomes including radiographic responses (complete response [CR], partial response [PR], stable disease [SD], progressive disease [PD]), progression free survival (PFS), overall survival (OS), and treatment-related adverse events (trAEs) were described. Clinical benefit rate (CBR) included CR, PR, or SD on imaging. Descriptive statistics were performed. At first lurbinectedin dose, all 18 patients had metastatic disease. Median age was 63.5 (Range: 53-84), number of prior systemic therapies was 4 (Range: 2-7), and lurbinectedin cycles completed was 5 (Range: 1-10). ADT was administered during lurbinectedin treatment in 9/18 patients. CBR was 9/16 (56%). The most common trAEs were fatigue and anemia. Median OS and PFS were 6.01 (0.23-16.69) and 3.35 (0.16-7.79) months. Lurbinectedin showed modest but significant clinical benefit in some patients with SC/NEPC and demonstrated an acceptable toxicity profile with no hospitalizations from trAEs. SC/NEPC is an aggressive disease with a poor prognosis for which more treatment options are needed. Evidence for subsequent treatments after platinum-based chemotherapy is lacking. Lurbinectedin is an active treatment option for SC/NEPC; however, larger confirmatory studies are needed.

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Disclosures Haley M Meyer. No Relationships to Disclose, Rajitha Sunkara, No Relationships to Disclose, Himisha Beltran, Consulting or Advisory Role - Amgen; AstraZeneca; Bayer; Blue Earth Diagnostics; Curie Therapeutics; Daicchi Sankyo; Foundation Medicine; Janssen Oncology; Loxo/Lilly; Merck; Novartis; Pfizer; Sanofi, Research Funding - Abbvie/Stemcentrx (Inst); Bristol Myers Squibb Foundation (Inst); Daiichi Sankyo (Inst); Janssen (Inst). Travel, Accommodations, Expenses - Janssen Oncology, Emily Rothmann, No Relationships to Disclose, Kevin Dale Courtney. Consulting or Advisory Role - Novartis, Research Funding - Amgen (Inst); Astellas Pharma (Inst); Astellas Pharma (Inst); AstraZeneca (Inst); Celgene/Bristol-Myers Squibb (Inst); Clovis Oncology (Inst); Exelixis (Inst); Harpoon therapeutics (Inst); Lilly (Inst); Myovant Sciences (Inst); Novartis (Inst); Pfizer (Inst); Stemline Therapeutics (Inst); Surface Oncology (Inst), Patents, Royalties, Other Intellectual Property - My spouse receives patent royalties from Athena Diagnostics, Inc. (I) Andrew J. Armstrong. Consulting or Advisory Role - Astellas Scientific and Medical Affairs Inc; AstraZeneca; Bayer; Bristol-Myers Squibb; Epic Sciences; Exelixis; GoodRx; Janssen; Merck; Myovant Sciences; Novartis; Pfizer; ZAlpha, Research Funding - Amgen (Inst); Astellas Pharma (Inst); AstraZeneca (Inst); Bayer (Inst); BeiGene (Inst); Bristol-Myers Squibb (Inst); Bristol-Myers Squibb (Inst); Constellation Pharmaceuticals (Inst); FORMA Therapeutics (Inst); Gilead Sciences (Inst); Janssen Oncology (Inst); Merck (Inst); Novartis (Inst); Pfizer (Inst); Roche/Genentech (Inst), Patents, Royalties, Other Intellectual Property - Circulating tumor cell novel capture technology (Inst), Travel, Accommodations, Expenses - Astellas Scientific and Medical Affairs Inc, Alan Haruo Bryce, Honoraria - Advanced Accelerator Applications/Novartis; Astellas Pharma; Astellas Pharma; AstraZeneca; Bayer; Bayer; Bayer; Castle Biosciences; Horizon CME; Janssen; Janssen Oncology; Lilly; Myovant Sciences; Myovant Sciences; Novartis; Novartis; Pfizer; Pfizer; Pfizer; Research to Practice; Research to Practice; Verity Pharmaceuticals; Verity Pharmaceuticals, Consulting or Advisory Role - Astellas Pharma, Research Funding - Janssen Oncology (Inst). Travel, Accommodations, Expenses - Bayer; Clovis Oncology (Inst); Pfizer; Pfizer (Inst); Phosplatin Therapeutics (Inst), Andrea Lippucci, Andrea Lippucci is currently a Genitourinary Oncology medical science liaison for Johnson and Johnson. The content production and involvement with this research project and manuscript were completed prior to her employment with Johnson and Johnson. This publication in no way reflects the viewpoint of Johnson and Johnson nor is it an endorsement of a particular treatment approach. Melissa L. Stanton, Consulting or Advisory Role - PAREXEL