publication date: Jun. 1, 2018

Clinical Roundup

Tecentriq plus chemo helped metastatic non-squamous NSCLC live longer vs. chemo alone

Genentech said the phase III IMpower130 study met its co-primary endpoints of overall survival and progression-free survival.

Genentech is a member of the Roche Group.

The combination of Tecentriq (atezolizumab) plus chemotherapy (carboplatin and Abraxane [albumin-bound paclitaxel; nab-paclitaxel]) helped people live significantly longer compared to chemotherapy alone in the initial treatment of advanced non-squamous non-small cell lung cancer.

In addition, the Tecentriq combination reduced the risk of disease worsening or death compared with chemotherapy alone. Safety for the Tecentriq and chemotherapy combination appeared consistent with the known safety profile of the individual medicines, and no new safety signals were identified with the combination. These data will be presented at an upcoming oncology congress.

Currently, Genentech has eight phase III lung cancer studies underway evaluating Tecentriq alone or in combination with other medicines. This is the third positive Phase III study evaluating TECENTRIQ alone or in combination to demonstrate an OS benefit for people with Tecentriq.

IMpower130 is a phase III, multicenter, open-label, randomized study evaluating the efficacy and safety of Tecentriq in combination with carboplatin and nab-paclitaxel versus chemotherapy (carboplatin and nab-paclitaxel) alone for chemotherapy-naïve patients with stage IV non-squamous NSCLC. The study enrolled 724 people who were randomized equally (1:1) to receive:

  • TECENTRIQ plus carboplatin and nab-paclitaxel (Arm A), or

  • Carboplatin and nab-paclitaxel (Arm B, control arm)

During the treatment-induction phase, people in Arm A received Tecentriq and carboplatin on day 1 of each 21-day cycle, and nab-paclitaxel on days 1, 8 and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit, whichever occurs first.

People received Tecentriq during the maintenance treatment phase until loss of clinical benefit was observed.

During the treatment-induction phase, people in Arm B received carboplatin on day 1 and nab-paclitaxel on days 1, 8 and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression, whichever occurs first.

People received best supportive care during the maintenance treatment phase. Switch maintenance to pemetrexed was also permitted. People who were consented prior to a protocol revision were given the option to crossover to receive Tecentriq as monotherapy until disease progression.

The co-primary endpoints were:

  • PFS as determined by the investigator using RECIST v1.1 in all randomized people without an EGFR or ALK mutation (intention-to-treat wild-type)

  • OS in the ITT-WT population

  • IMpower130 met its OS and PFS co-primary endpoints.


Lung cancer risk drops substantially within five years of quitting smoking

The main findings of a new analysis of the landmark Framingham Heart Study by researchers at Vanderbilt University Medical Center published May 16 by the Journal of the National Cancer Institute shows that the risk of lung cancer drops substantially within five years of quitting.

First author Hilary Tindle, the William Anderson Spickard Jr., MD Professor of Medicine at the Vanderbilt University School of Medicine and director of the Vanderbilt Center for Tobacco, Addiction and Lifestyl aand her colleagues examined the health records of residents of Framingham, Massachusetts, who have been followed for decades by the Framingham Heart Study.

The study, which is supported by the National Heart, Lung, and Blood Institute, helped establish high blood pressure and high cholesterol as key risk factors for cardiovascular disease. But it also tracked cancer outcomes.

The current study looked at 8,907 participants who had been followed for 25 to 34 years. During this period, 284 lung cancers were diagnosed, nearly 93 percent of which occurred among heavy smokers, those who had smoked at least a pack of cigarettes a day for 21 years or more.

Five years after quitting, the risk of developing lung cancer in former heavy smokers dropped by 39 percent compared to current smokers, and continued to fall as time went on. Yet even 25 years after quitting, their lung-cancer risk remained over threefold higher compared to people who had never smoked.

The Framingham study is unique because it asked people about their smoking every two to four years, and could account for increases or decreases in smoking over time.

Current federal guidelines, which mandate insurance coverage of lung cancer screening for current and former smokers, exclude those who haven’t smoked for 15 years or more. Yet four of 10 cancers in heavy smokers in the current study occurred more than 15 years after they quit.

Further study is warranted to determine whether extending the cut-off point for mandated screening would be cost-effective and save lives, the researchers concluded.

The senior author is Matthew Freiberg professor of Medicine and founding director of the Vanderbilt Center for Clinical Cardiovascular Outcomes Research and Trials Evaluation.

Other Vanderbilt co-authors were Pierre Massion, Cornelius Vanderbilt Professor of Medicine; Robert Greevy, associate professor of Biostatistics; Meredith Stevenson Duncan, V-CREATE database administrator; and Suman Kundu, associate database administrator in the Division of Cardiovascular Medicine and V-CREATE.

Vasan Ramachandran, principal investigator of the Framingham Heart Study and professor of Medicine at Boston University, also contributed to the study.

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