(PharmaTimes [UK]) Dec 7, 2018 - AstraZeneca and MedImmune’s Imfinzi has failed to hit targets in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). The Phase III EAGLE trial assessed Imfinzi (durvalumab) monotherapy or Imfinzi in combination with tremelimumab, an anti-CTLA4 antibody, versus standard-of-care (SoC) chemotherapy in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) who experienced disease progression following platinum-based chemotherapy, regardless of their PD-L1 tumour status.

Howard S. Hochster, MD (Posted: December 08, 2018)

Once again, despite our hopes, and the imagination of the public, that a magic-bullet immunotherapy will work globally, we see the limitations of the IO approach. We justify possible activity on the basis of smoking-induced cancers or viral-induced, yet these cancers (like many solid tumors) are not melanoma. The era of continuing to throw anti-PD(L)1 and anti-CTLA4 agents against the wall and seeing what sticks needs to end. Let’s be smarter and try to select the appropriate patients using predictive markers!

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(Morningstar/Dow Jones Newswires) Dec 6, 2018 - Genentech, a member of the Roche Group, on Thursday said the U.S. Food and Drug Administration approved Tecentriq and chemotherapy for some patients with a certain type of lung cancer. Genentech said the FDA gave its approval to Tecentriq in combination with Avastin, paclitaxel and carboplatin for the first-line treatment of patients with metastatic non-squamous non-small cell lung cancer, with no EGFR or ALK genomic tumor aberrations.

H. Jack West, MD (Posted: December 07, 2018)

While it's nice to have a new approval, this is also a setting in which the IMpower150 regimen offers nothing beyond what we already have with the KEYNOTE-189 trial regimen of platinum/pemetrexed/pembrolizumab, except alopecia and neuropathy risk. The only real setting in which there is an unmet need now is for those patients with an EGFR mutation or ALK rearrangement who have received and progressed on a prior tyrosine kinase inhibitor -- these patients have been excluded from nearly all of the trials for chemotherapy +/- immunotherapy, but the carbo/paclitaxel/bev/atezo arm was associated with a PFS and OS benefit in EGFR mutation-positive patients at least as strong with addition of atezo to carbo/pac/bev as was seen in the broader population (not as clear that this can be said for ALK-positive patients). Unfortunately, the FDA approval specifically excludes patients with an EGFR mutation or ALK rearrangement, so I anticipate that this approval will (and should) have minimal impact on practice patterns, and we are left with no clear direction on how to approach patients with acquired resistance and EGFR mutation-positive NSCLC.

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(Investor’s Business Daily) Dec 4, 2018 - Clovis Oncology stock surged Tuesday after a European patent decision averted a "worst case" scenario for its ovarian cancer treatment, Rubraca.

Debu Tripathy, MD (Posted: December 05, 2018)

Very interesting

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