NorthWest Biotherapeutics Inc (NWBO)

[longfellow95]

Wow, this Italian group don't mince their words on HPD in lung cancer (by far the biggest ICI market):-

Hyperprogressive disease in lung cancer and other tumors is an urgent clinical issue affecting 1 of 5 patients treated with immune checkpoint inhibitors (ICI), affecting their prognosis and leading to death in a very short time. As the use of immunotherapy increases in the clinic, it is important to understand the intricacies of this new treatment option to optimize treatment approaches. Data already published in the field mainly focused on adaptive immunity without finding any characteristics to predict a priori the phenomenon. Our preclinical findings underline the role of innate immunity in mediating hyperprogression (HP) via Fc/FcR triggering on macrophages by anti–PD-1 antibody. Accordingly, all patients with HP showed tumor infiltration by M2-like CD163+CD33+PD-L1+ clustered epithelioid macrophages. These results, pointing to the involvement of innate immune cells in HP, provide new insights into the still unknown mechanisms behind a clinical conundrum.

And:-

Although ICI have changed the paradigm of care for patients with NSCLC, an in-depth examination of the Kaplan–Meier curves from the CheckMate-026 (14), CheckMate-057 (15), CheckMate-227 (16), and KEYNOTE-042 (17) trials showed an excess of disease progression and death in the immunotherapy treatment arms compared with chemotherapy in the first 3 months of treatment. This was also underscored by the European Medicines Agency in response to the appraisal for the second-line use of nivolumab in nonsquamous histologies (www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003985/WC500189765.pdf).

http://clincancerres.aacrjournals.org/content/25/3/989?iss=3

And still the FDA are silent...
Merck is expected to turn over $10 billion on Keytruda alone this year with BMY not far behind with Nivo.

How can the FDA say the ICI's are safe?