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Survival – Primary Endpoint in Majority of the Market Products

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Clinical Trial Endoints in Oncology - Inclusion of Surrogate Endpoints and Shorter Endpoints will Ensure Faster Clinical Trials in Oncology


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Survival – Primary Endpoint in Majority of the Market Products

The primary endpoint for the approval of drugs in the oncology markets, which included colorectal, ovarian, head, neck and prostate cancer, was survival. The other endpoints in these markets were response rate (complete, partial, objective, overall response rate and so on). The major marketed drugs approved after 1990 in the colorectal cancer market were Camptosar (irinotecan), Xeloda (capecitabine), Avastin (Bevacizumab), Erbitux (cetuximab), Vectibix (panitumumab) and Eloxatin (oxaliplatin). The primary endpoint in all these drugs was survival, followed by median time to tumor progression, tumor response rate, progression-free survival, overall response rate and duration of response. In the prostate cancer market, the major marketed products were Taxotere (docetaxel), Casodex (Bicalutamide), Zoladex (Goserelin), Provenge (sipuleucel-T), Eligard (leuprolide acetate), Prostap (leuprolide acetate), Firmagon (degarelix), Vantas (Histrelin), Novantrone (Mitoxantrone hydrochloride), Trelstar (triptorelin). The primary and secondary endpoints in these included the median survival rate, prostate specific antigen (PSA) response, overall tumor response rate, disease-free survival, objective response, serum testosterone level and time to disease progression.


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The major marketed drugs after 1990 approved for head and neck cancer were Erbitux (cetuximab), Taxotere (docetaxel), Oncorine (H101, Modified Adenovirus) and Gendicine (Recombinant Human Ad-P53). The primary and secondary endpoints in these included median and overall survival rate, progression-free survival and complete response rate. Similarly, the major marketed drugs after 1990 approved for ovarian cancer were Altretamine (Hexalen), Gemcitabine (Gemzar), Hycamtin (Topotecan hydrochloride) and Yondelis (trabectedin). The primary and secondary endpoints of these drugs included overall and complete response rate, progression-free survival, time to response and overall survival.

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Survival Followed by Progression Free Survival, Disease Free Survival and Time to Progression as Endpoints in Phase III Clinical Trials

The Phase III clinical trial endpoint was predominantly survival, followed by progression free survival (PFS), disease free survival (DFS) and time to progression (TTP). Approximately 66% of the colorectal cancer pipeline


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candidates in the Phase III have either survival or PFS as their primary endpoint. Out of this 66%, 43% have survival and 23% have PFS as the endpoint. In addition to survival and PFS, 11% of the molecules have DFS, 7% of molecules have response rate and 5 % of the candidates have TTP as the endpoint. The Phase III clinical trial pipeline for prostate cancer was dominated

with either survival or PFS for endpoints, as approximately 45% of the total pipeline was contributed by them together. In addition to survival and PFS, 14% of the molecules have testosterone level, 13% of molecules have tumor response rate and 8 % of the candidates have others as endpoints. Also, approximately 29% of the head and neck cancer pipeline candidates in Phase III trials have overall survival as the endpoint. In addition to overall survival, 8% of the molecules have TTP and 4% of the candidates have PFS are the endpoint. Approximately 44% of the ovarian cancer pipeline candidates in Phase III have PFS as the endpoint. In addition to PFS, the molecules have overall survival as the major endpoint.

Response Rate as the Endpoint in Phase II Clinical Trials

Approximately 32% of the colorectal cancer pipeline candidates in Phase II trials have response rate, which includes complete response rate, best response rate and tumor response rate, as the endpoint. Of the remainder, 25% have PFS and 27% have other endpoints (safety, efficacy, dosage, toxicity


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and tolerability). Approximately 35% of prostate cancer pipeline candidates in Phase II trials have tumor response rate, which includes complete response rate, objective response rate and PSA response rate, as the endpoint. Approximately 48% of the head and neck cancer pipeline candidates in Phase II trials have response rate, which includes best overall response rate and objective tumor response rate, as the endpoint. Approximately 37% of the ovarian cancer pipeline candidates in Phase II trials have response rate, which includes best overall tumor response, clinical response, and complete response rate, as the endpoint.

Safety Issues, Lack of Improvement in Survival Rates and Failure to Meet Primary Endpoints Led to Discontinuation of Clinical Trials

In the colorectal cancer market, Vectibix treatment has been discontinued due to safety issues. A study showed that there were issues with the safety of patients. The analysis revealed a statistically significant difference in progression-free survival in favor of the control arm. Overall survival demonstrated a statistically significant difference favoring the control arm. In 2009, Pfizer discontinued a Phase III trial of the drug for the treatment of prostate cancer after it failed to offer a significant progression-free survival benefit. This was followed by further failures in the treatment of breast, liver and lung cancers, substantially curtailing its potential indications.


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Iressa (gefitinib) failed to prolong survival and increased bleeding events, leading to discontinuation of its clinical trial for the treatment of Squamous Cell Carcinoma of the Head and Neck (SCCHN). In addition to this, clinical development of bivatuzumab mertansine was discontinued before reaching its maximum tolerated dose. The main toxicity of bivatuzumab mertansine was directed against the skin, most probably due to CD44v6 expression in this tissue. The majority of skin reactions were reversible; however, one fatal drug-related adverse event occurred.

In the ovarian cancer market, Ovarex and Pemtumomab were discontinued due to failure to meet the primary endpoint.

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For more details contact: bleeding events, leading to discontinuation of its clinical trial for the treatment of Squamous Cell Carcinoma of the Head and Neck (SCCHN). In addition to this, clinical development of bivatuzumab mertansine was discontinued before reaching its maximum tolerated dose. The main toxicity of bivatuzumab mertansine was directed against the skin, most probably due to CD44v6 expression in this tissue. The majority of skin reactions were reversible; however, one fatal drug-related adverse event occurred.

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