One of the most impressive data sets presented at this year's annual ASCO meeting was from Roche's J-ALEX study – a Phase III head-to-head trial of Alecensa versus Xalkori in treatment-naïve ALK-positive non-small-cell lung cancer (NSCLC) patients.
At a pre-specified interim analysis, median progression-free survival (PFS) was not reached in patients who received Alecensa versus a 10.2 month median PFS in those who received Xalkori. With an observed hazard ratio of 0.34, Alecensa was shown to reduce the risk of disease worsening or death by 66 percent versus Xalkori, while there were also fewer side effects in the Alecensa arm.
Citing J-ALEX as "one of the most important data sets," to come out of ASCO, Jared Weiss – section chief of thoracic and head/neck oncology, University of North Carolina School of Medicine, Chapel Hill NC – told FirstWord the data "supports the idea of using the most potent agent up front to prevent the emergence of resistance." Weiss, who had previously been sceptical of using a second-generation tyrosine kinase inhibitor in first-line patients and had expected the toxicity profiles of Alecensa and Xalkori to be comparable, concedes "I was wrong on both counts."
Weiss says the data are particularly important given the relatively small number of lung cancer patients that are tested as being ALK-positive; "the results provide a rather important lesson for oncologists like me who may treat only a small number of patients with these drugs over the course of a year, which means we need hard data."
Roche hopes to replicate these data in the ongoing ALEX study (a non-Japanese specific version of J-ALEX), which may be required for US and EU approval of Alecensa in first-line patients. Results are expected early in 2017.
In the meantime, FirstWord's latest Physician Views poll aims to provide additional insight on oncologist awareness of the J-ALEX data and whether usage is already occurring in first-line patients on an off-label basis. Specifically, we are asking US oncologists…
Are you based in a community or academic setting?
How impressed have you been with alectinib for the treatment of ALK-positive non-small-cell lung cancer (NSCLC)?
Are you using alectinib in first-line ALK-positive NSCLC patients now or anticipating usage pre-approval?
Yes – very occasionally
Yes – occasionally
Yes – frequently
Yes – very frequently
How impressed are you with data from the Phase III J-ALEX study (head-to-head versus crizotinib in first-line patients)?
Based on your experience and available data, how confident are you that alectinib will become established as the new standard of care in first-line ALK-positive NSCLC?
Results and related analysis will be published for FirstWord Pharma PLUS subscribers to read, with the opportunity for non-FirstWord Pharma PLUS subscribers to purchase these findings. To be notified when poll results and analysis become available, please click here.
As always, FirstWord would very much like to receive your feedback and suggestions. Note: FirstWord Polls are powered by MedePolls, a fast-turnaround service to conduct instant polls of up to five questions with guaranteed samples that include physicians from dozens of specialties and over 100 markets. To conduct this poll with a different audience, or an entirely different poll, contact us at email@example.com
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