ImmunoGen stops cancer trial
pharmafile | November 6, 2013 | News story | Research and Development, Sales and Marketing | Cancer, IMGN901, Immunogen, Roche
Roche subsidiary ImmunoGen has abandoned a Phase II trial into small-cell lung cancer (SCLC) after deciding that it was not going to show any benefit.
The company’s IMGN901, a CD56-targeting antibody-drug conjugate (ADC), was added to chemotherapy agents etoposide and carboplatin (E/C) but the company concluded it “was unlikely to demonstrate a sufficient improvement in progression-free survival compared to E/C alone to justify continuation of the trial”.
Of the 198 patients receiving IMGN901 as a single agent in early trials, one died of an infection that “was deemed possibly drug-related”, the firm said.
ImmunoGen said there was an ‘imbalance’ in the rate of infection and infection-related deaths between the arms of the trial, which led the programme’s independent data monitoring committee to recommend stopping the process.
“This is clearly a disappointing outcome, as there is a tremendous need for new treatment options for SCLC,” said ImmunoGen chief development officer Charles Morris.
“We will be analysing the findings to date in this trial as part of assessing potential next steps for IMGN901,” he said.
ImmunoGen says it is now “updating study investigators and regulatory authorities”.
Roche’s Kadcyla, approved in the US and Japan, and recommended by the CHMP in Europe, is ImmunoGen’s most advanced ADC.
Over the past 18 months, the company has begun clinical testing with three more ADC compounds: IMGN853 for ovarian and endometrial cancer, IMGN529 for non-Hodgkin lymphoma and IMGN289.
The latter contains an EGFR-targeting antibody, with a design also used in Kadcyla, and will be investigated in squamous cell carcinoma of the head and neck cancer (SCCHN), non-small cell lung cancer (NSCLC) and NSCLC which is resistant to EGFR inhibitors.
In pre-clinical testing, the antibody component of IMGN289 was found to be very active against EGFR-positive tumours responsive to EGFR inhibitors, the company said.
Adam Hill
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