Blood clot fears halt cancer trial enrolment
pharmafile | February 3, 2011 | News story | Research and Development |Â Â BMS, Bristol-Myers Squibb, Eli Lilly, NSCLC, lilly, necitumumab, non small cell lung cancer, non-small cell lung cancerÂ
Lilly and BMS have stopped enrolment in a phase III trial of necitumumab, a new treatment for non-small cell lung cancer.
New enrolment to the INSPIRE trial was stopped after an independent Data Monitoring Committee (DMC) detected a raised risk of blood clots in patients receiving the drug.
Necitumumab is a fully-human IgG1 monoclonal antibody and the INSPIRE trial is investigating its use in combination with Alimta (pemetrexed) and cisplatin compared to a regimen of Alimta and cisplatin, as a first-line treatment for patients with advanced non-squamous NSCLC. No new safety issues were seen in the control arm with Alimta and cisplatin.
Patients who have already received two or more cycles of necitumumab appear to have a lower ongoing risk of clots, and these patients may choose to remain on the trial, after being informed of the additional potential risks. Investigators will continue to assess patients after two cycles to determine if there is a potential benefit from treatment.
The drug will continue to be studied in a parallel phase III trial named SQUIRE, which is investigating its use in squamous rather than non-squamous non-small cell lung cancer. In this trial, the drug is being combined with Gemzar (gemcitabine) and cisplatin. The DMC says this trial can continue because no safety concerns have been observed.
“Patient safety is paramount. While stopping enrolment in one of the two phase III trials is disappointing, the SQUIRE phase III study of necitumumab in lung cancer continues,” said Richard Gaynor, vice president, oncology product development and medical affairs for Lilly. “Lilly remains committed to developing new medicines that can help treat this devastating disease.”
Andrew McConaghie
Related Content
Lilly opens fourth US Gateway Labs site
Eli Lilly has opened its newest Lilly Gateway Labs (LGL) site in San Diego, California, …
HUTCHMED completes enrolment in phase 3 trial for lung cancer
HUTCHMED has completed patient enrolment for the SANOVO phase 3 clinical trial, investigating the use …
Lilly’s drug for early Alzheimer’s shows promising results
Eli Lilly (Lilly) has announced positive new data from the long-term extension of its phase …
