(New York Times) Feb 7, 2019 - The fossil of an ancient animal teaches a sad lesson: Cancer has been around for a very, very long time. Certainly the patient never knew where the hip pain came from, or why its left leg stopped working. The diagnosis arrived only 240 million years later, when a femur turned up in an ancient lake bed in Germany, one side marred by a malignant bone tumor. Cancer seldom appears in the fossil record, and its history among vertebrates is poorly understood. On Thursday, a team of researchers writing in JAMA Oncology have described the femur as the oldest known case of cancer in an amniote, the group that includes reptiles, birds and mammals.

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H. Jack West, MD (Posted: February 08, 2019)

"Paleo pathology" is cool. Cancer goes back to the Triassic period.

(Xconomy New York) Jan 24, 2019 - Bristol-Myers Squibb has lost yet more ground in its ongoing cancer immunotherapy battle with rival Merck. Along with its earnings, the pharma firm reported Thursday that it has pulled a key approval application to use a combo regimen of its already approved immunotherapies, nivolumab (Opdivo) and ipilimumab (Yervoy), in a portion of patients with newly diagnosed, advanced non-small cell lung cancer (NSCLC). Specifically, Bristol said that, upon discussions with the FDA, it needs more data to support the approval filing. The problem: Bristol needs to provide additional evidence for “the relationship between [tumor mutational burden] and PD-L1”—two biomarkers meant to help identify patients who might respond to immunotherapy—to really tell if the Bristol regimen is helping patients live longer.

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H. Jack West, MD (Posted: January 24, 2019)

We are not privy to the data that the FDA have, but based on the TMB data that are publicly available, I think this is a very appropriate guidance by the FDA. We need more and stronger data to support TMB use for clinical decision-making. First, we need to see a survival benefit by using it; second, we need to see that the survival benefit is predicated on using the TMB test. I think it is more likely than not that TMB will be a useful biomarker, but not the only one, in a few years. However, the data we've seen from CheckMate-227 are not sufficient to warrant using it.

(Roche) Jan 17, 2019 - Roche today announced that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Tecentriq® (atezolizumab) in combination with Abraxane® [albumin-bound paclitaxel; nab-paclitaxel]) and carboplatin for the initial (first-line) treatment of people with metastatic non-squamous non-small cell lung cancer (NSCLC) who do not have EGFR or ALK genomic tumour aberrations. The FDA is expected to make a decision on approval by 2 September 2019. “We look forward to working with the FDA in order to bring this Tecentriq-based combination to people with non-squamous non-small cell lung cancer as soon as possible,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “Lung cancer is a challenging disease to treat, and this review takes us one step closer towards offering a new treatment option that has shown a clinically meaningful survival benefit in the treatment of this type of disease.”

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H. Jack West, MD (Posted: January 17, 2019)

This application is based on the results of the IMpower130 trial of first line carbo/nab-paclitaxel with or without atezolizumab in patients with advanced non-squamous NSCLC (disclosure: I am an author on the abstract presented thus far and future publication). The trial is positive for not just an improvement in progression-free survival but also overall survival, which is an achievement. However, I see the limiting factor being that the true comparator in this setting today isn't chemotherapy alone, as was in the trial, but the KEYNOTE-189 combination of carbo/pemetrexed/pembrolizumab in the same setting. Though there can always be an occasion for which an alternative to the carbo/pemetrexed backbone is needed, this chemo regimen and the KEYNOTE-189 combination in general is one that the vast majority of lung cancer specialists and general oncologists alike are very happy to use as their preferred regimen. This will likely relegate the IMpower130 combination being considered here to very, very limited use. There is simply little to no incremental benefit it offers over KEYNOTE-189 in the same setting.