LGBT Cancer Project

Thyroid Cancer

March 5, 2018

Intensity Therapeutics announced completion of the first safety cohort (A) of the Company’s Phase 1/2 international clinical study evaluating lead product, INT230-6. Following intratumoral drug injections into superficial lesions in six patients with either ovarian, thyroid, head and neck or skin cancers, there were no dose limiting toxicities. INT230-6 is a novel, anti-cancer drug for direct intratumoral injection. The product contains potent anti-cancer agents that disperse throughout tumors and diffuse into cancer cells. INT230-6 was identified from Intensity’s DfuseRx platform and is being evaluated in a clinical trial; IT-01. In preclinical studies INT230-6 administration eradicated tumors by a combination of direct tumor kill coupled with recruitment of dendritic cells to the tumor micro-environment that induced anti-cancer T-cell activation. The study will characterize the systemic pharmacokinetic profile of multiple doses of INT230-6’s drug substances after single and then multiple intratumoral injections. Exploratory analysis will characterize patient outcome, as well as evaluate various tumor and anti-tumor immune response biomarkers that may correlate with response.

February 17, 2014

Eisai reported positive results of a phase III trial of lenvatinib for the treatment of radioiodine-refractory differentiated thyroid cancer (RR-DTC). The study was a multicenter, randomized, double-blind, placebo-controlled, phase III study to compare the PFS of patients with radioiodinerefractory differentiated thyroid cancer and radiographic evidence of disease progression within the prior 12 months, treated with once-daily, oral lenvatinib (24mg) v. placebo. Secondary endpoints of the study included overall response rate (ORR), overall survival (OS) and safety. The study enrolled 392 patients at over 100 sites in Europe, North and South America and Asia. The preliminary safety analyses showed the five most common adverse reactions were hypertension, diarrhea, decreased appetite, decreased weight and nausea. Based on positive clinical results, Eisai will submit marketing authorization applications for lenvatinib to health authorities in the U.S., Japan and Europe.

October 31, 2011

Exelixis released results from a phase III trial of cabozantinib for the treatment of medullary thyroid cancer. This randomized, placebo-controlled, double-blinded study, EXAM, enroll 315 subjects with unresectable, locally advanced, or metastatic thyroid cancer. The subjects received cabozantinib or placebo administered as a daily oral dose of 175 mg. The primary endpoint was a 75% improvement in progression free survival (PFS). The trial met the primary endpoint and substantially exceeded the threshold of a 75% increase. Cabozantinib significantly improved median PFS by 7.2 months compared with placebo. The median PFS on the cabozantinib arm was 11.2 months versus 4.0 months on the placebo arm (p<0.0001).

June 6, 2011

Eisai released preliminary results from a phase II trial of lenvatinib for the treatment of thyroid cancer. This open-label, global, single-arm trial enrolled 58 subjects with advanced radioiodine-refractory differentiated thyroid cancer whose disease had progressed during the prior 12 months. The subjects received lenvatinib at a starting dose of 24 mg once daily in 28-day cycles until disease progression or development of unmanageable toxicities. Data showed an Objective Response Rate of 59%. Lenvatinib was well tolerated.

September 20, 2010

OXiGENE issued positive results from a phase II/III trial of Zybrestat for the treatment of anaplastic thyroid cancer. This randomized and controlled trial, dubbed FACT (fosbretabulin in anaplastic cancer of the thyroid), enrolled 80 subjects who received intravenous Zybrestat (dosed at 60 mg/m2) plus carboplatin and paclitaxel or carboplatin and paclitaxel alone. The primary endpoint was a statistically significant difference in overall response between the two treatment arms. The median overall survival (OS) was 5.1 months for patients who received Zybrestat and chemotherapy and 4.1 months for patients who received chemotherapy alone. At six months, 48% of the Zybrestat cohort was alive compared to 37% of the chemotherapy alone cohort. At one year, 23% of the Zybrestat cohort was alive compared to 9% of the chemotherapy alone cohort. Zybrestat in conjunction with chemotherapy was well tolerated.

March 23, 2009

OxiGENE reported positive results from a phase II trial of fosbretabulin for the treatment of anaplastic thyroid cancer (ATC). This US-based monotherapy trial enrolled 26 subjects with advanced or metastatic ATC who had progressed or relapsed following initial therapy. Fosbretabulin was administered on days 1, 8 and 15 of each 28-day cycle in a 10-minute intravenous infusion of 45 mg/m2. A total of 77 cycles of therapy were administered with a median of two cycles per subject. Treatment was continued until disease progression. Seven subjects (27%) experienced stable disease for at least six weeks, with a median duration of 12.3 months. The median survival was 4.7 months, with 34% of subjects alive at six months and 23% of patients alive at 12 months. Event-free survival at three months was 23.1% and at six months was 7.7%. Three subjects were alive at the time of last follow-up at 12.1, 24.4 and 37.9 months. Fosbretabulin was well-tolerated.

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