Date: 2015-06-01
Type of information: Presentation of results at a congress
phase: 1b
Announcement: presentation of results at the American Society of Clinical Oncology (ASCO) annual meeting, in Chicago
Company: PharmaMar (Spain)
Product: PM1183 plus doxorubicin
Action
mechanism: transcriptional inhibitor. PM01183 is a novel synthetic marine-derived compound that covalently binds to the minor groove of the DNA. These PM01183-DNA adducts give rise to double strand breaks and perturbations of the cell cycle inducing cell death. PM01183 induces a specific degradation in tumour cells of RNA polymerase II, without interfering other RNA polymerases (I and III)-the degradation depends on whether the transcription process is active (transactivated transcription) and does not affect basal transcription. In preclinical trials, the compound evidenced strong activity against tumour cell lines of different origins.
Disease: small cell lung cancer
Therapeutic area: Cancer - Oncology
Country:
Trial
details: This Phase 1b study is an expansion cohort of approximately 20 evaluable SCLC patients that have failed after one chemotherapy-containing prior line to assess in second line treatment the remarkable activity of the combination treatment (71% of objective partial responses[iv]) previously observed during the escalation phase. After 12 months of follow up, the overall response rate as measured by RECIST criteria was 67% and a complete response was achieved by 10% of the patients. Durable responses were observed with an overall PFS of 4.6 months (4.8 months in sensitive patients and 3.6 months in resistant patients).
Latest
news: * On June 1st 2015, PharmaMar announced data from a Phase 1b study of the transcriptional inhibitor PM1183 in combination with doxorubicin in second line therapy in patients with small cell lung cancer (SCLC) showing that the treatment induced objective responses in 67% of the patients, including 10% of them where all signs of cancer disappeared (complete responses). Every patient with SCLC denominated primary chemotherapy-sensitive (their chemotherapy-free interval (CTFI) is more than 90 days) responded to treatment, including 18% of complete responses. In primary chemotherapy-resistant patients, where cancer was progressing within 90 days or less of previous chemotherapy, a remarkable 30% achieved a response. Notably, the treatment resulted in durable responses, with an overall progression-free survival (PFS) of 4.6 months, which was 3.6 months in resistant patients. The most common adverse drug reaction was reversible myelosuppresion but no cardiotoxicity or drug-related deaths were observed.
The lead author Dr. Martin Forster, University College Hospital, London, UK. has presented the full data at the 51th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Abstract#7509).
