Marine Drug Goes to Phase III Trials to Treat Lung Cancer

Excerpt:

“PharmaMar is starting a new Phase III trial, with patients suffering from small cell lung cancer (SCLC). It’ll test the efficacy of its third candidate obtained from marine organisms (PM1183) as a SCLC treatment.

“PharmaMar is one of the hot Biotechs in Spain, which just saw its second drug finish Phase III trials with good results (and is already in trials for other indications, as we’ve seen at ASCO).

“Now, PM1183 is under the spotlight. This cancer drug will be used in a second Phase III trial (after ovarian cancer). It’ll enrol 600 patients with small cell lung cancer (SCLC), for whom platinum-based treatments have failed before.”

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Small Cell Lung Cancer at ASCO: Some Welcome News


Small cell lung cancer (SCLC) is a fatal disease that has not seen new drug approvals for the last 17 years. Considering the relative success of ‘immune checkpoint inhibitors’ in non-small cell lung cancer (NSCLC), it is not surprising that several abstracts recently presented at the 2015 American Society of Clinical Oncology (ASCO) annual meeting were devoted to clinical trials testing these trendy, immune system-boosting drugs in people with SCLC. Continue reading…


PharmaMar's Investigational Drug PM1183 plus Doxorubicin Shows Remarkable Activity in Small Cell Lung Cancer

“PharmaMar today 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 rate, depth and length of responses that we have observed with this treatment in the second-line setting are remarkable, even in those patients that are usually considered harder to treat”, said Dr. Martin Forster, University College Hospital, London, UK.

“ ‘Small cell lung cancer is an unmet clinical need with very few recent advances and the scientific community is committed to help new develop effective therapies.’ ”


PharmaMar Announces New Advances in Oncology at ASCO 2015 for Its Compounds YONDELIS® and PM1183 in Small Cell Lung Cancer, Soft Tissue Sarcoma, and Mesothelioma

“PharmaMar announces that it will present several clinical studies to showcase the data obtained in various tumor types, including SCLC, soft tissue sarcoma and mesothelioma during the 51st American Society of Clinical Oncology meeting in Chicago (ASCO; May 29-June 2). Abstracts have been selected for oral presentation, poster discussion session and general poster presentation. The studies presented by the Company will include the first-in-class drug YONDELIS® (trabectedin), and the second-generation of this class, PM1183 (lurbinectedin). PM1183 is an inhibitor of the transcriptional machinery and a DNA repair complex, which have proven to be crucial in different tumor types, including SCLC, soft tissue sarcoma and ovarian cancer. In addition, these drugs have been shown to have an effect on the tumor microenvironment by targeting tumor-associated macrophages, which is relevant for cancers such as mesothelioma and ovarian cancer, in which chronic inflammation seems to be a hallmark of the disease.”


After Promising Early Results, Drug to Continue Testing in More Relapsed SCLC Patients

The gist: In a clinical trial, a new drug called PM1183 showed promise for treating people with small cell lung cancer (SCLC). Based on those results, the drug will be tested in more people in a new phase III clinical trial. PM1183 will be given to patients along with the drug doxorubicin. For comparison, some patients will only be treated with the drug topotecan. The trial will enroll patients who have SCLC that returned (relapsed) after standard treatment.

“Zeltia announces today that its pharmaceutical division PharmaMar will start a Phase III trial with PM1183 in combination with doxorubicin against topotecan in SCLC, given the activity observed in an interim analysis of an ongoing Phase Ib trial. The results of this study will be presented at a prominent international cancer meeting this year, which will be soon announced.

“Patients with small cell lung cancer (SCLC) after failure of standard chemotherapy, as well as bladder, gastric, breast, endometrial or ovarian cancer, neuroendocrine tumors and soft-tissue sarcomas were treated with the combination in a Phase I. The treatment showed efficacy across all cancer types, including several complete responses. This clinical response was remarkable in certain tumor types, particularly in SCLC, and consequently more patients with this type of tumor were enrolled. The treatment was generally well-tolerated, and these patients had marked objective tumor responses and were able to receive several cycles of treatment.

” ‘The data we have are very exciting as patients with SCLC have the worst prognosis among lung cancer patient. There have been no significant advances in 25 years in this type of lung cancer.’ says Luis Mora, Managing Director, PharmaMar.”