Immunotherapy Needs a New Math

Excerpt:

“A group of doctors and other healthcare industry professionals have set out to develop a more efficient tool for assessing the true value of immuno-oncology (I/O) drugs. They note that these drugs often come with high prices that may distract from their advantages over other types of therapy. For example, Kroger Pharmacy is selling the checkpoint inhibitor ipilimumab (Yervoy) for $140 per mg. At the recommended dose of 3 mg/kg for melanoma patients, the total expense can be high. However, ipilimumab is one of the class of I/O drugs that have improved expectations on supportive care costs and survival benefit. The old measures of value may not apply. Therefore, how does one determine whether $140/mg is a fair price for the drug?”

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Nab-Paclitaxel Paired With Anti-PD-L1 Immunotherapies in TNBC Studies

Excerpt:

“Combination regimens that pair nab-paclitaxel (Abraxane) with PD-L1 checkpoint blockade immunotherapy agents are emerging as a robust area of investigation in triple-negative breast cancer (TNBC), bolstered by clinical trial results that establish the chemotherapeutic agent as an effective partner for other therapies.

“Although nab-paclitaxel has been combined in some studies with other chemotherapies, the focus is shifting to regimens that include immunotherapies as the efficacy of that approach continues to grow. Nab-paclitaxel, an albumin-bound form of paclitaxel, is indicated for patients with metastatic breast cancer after prior chemotherapy.”

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The Next Few Years Will Bring Stunning Progress for TNBC, Expert Says

Excerpt:

“The treatment landscape for triple-negative breast cancer (TNBC) is transforming, experts say, with the potential additions of immunotherapy and PARP inhibitors. These agents are being explored both as monotherapy and in combination regimens with standard chemotherapy options.

“At the 2016 San Antonio Breast Cancer Symposium, treatment with pembrolizumab (Keytruda) continued to show a consistent durable benefit with an additional year of follow-up for heavily pretreated patients with recurrent PD-L1–positive TNBC, according to findings from the phase Ib KEYNOTE-012 trial.”

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Scientists Discover Why Some Cancers May Not Respond to Immunotherapy

Excerpt:

UCLA scientists have discovered that people with cancers containing genetic mutations JAK1 or JAK2, which are known to prevent tumors from recognizing or receiving signals from T cells to stop growing, will have little or no benefit from the immunotherapy drug pembrolizumab. This early-stage research has allowed them to determine for the first time why some people with advanced melanoma or advanced colon cancer will not respond to pembrolizumab, an anti-PD-1 treatment.

“The study, led by Dr. Antoni Ribas, director of the UCLA Jonsson Comprehensive Cancer Center Tumor Immunology Program, also found that JAK1 or JAK2 genetic mutations led to a loss of reactive PD-L1 expression.  PD-L1 is an immune biomarker expressed on tumor cells and pembrolizumab requires an abundance of it to effectively attack cancer cells.”

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Immunotherapy 2.0 Named Advance of the Year in ASCO’s 12th Annual Cancer Progress Report

Excerpt:

“A growing number of patients with cancer are benefitting from research advances in immunotherapy, leading the American Society of Clinical Oncology (ASCO) to name immunotherapy as the Society’s advance of the year for a second year in a row. Released today, this year’s report, Clinical Cancer Advances 2017: ASCO’s Annual Report on Progress Against Cancer highlights the expanding role of immunotherapy. Evolving research findings are providing new insights on how to get the optimal results from these relatively new treatments.”

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Concerns That Rosy Direct-To-Consumer Ads Hype Cancer Drugs To Vulnerable Patients

Excerpt:

“A few weeks ago, I was watching veg-out TV, quietly wondering to myself how a show called ‘Pure Genius’ could be so darned dumb.

“Then a commercial break added a new sort of mystification: A long, vivid ad touted the cancer drug Opdivo, a form of immunotherapy — an exciting new type of treatment that harnesses the body’s own immune system — for lung cancer.

“Lung cancer is the biggest cancer killer, so, in this anomalous country that allows direct-to-consumer drug ads, it was no surprise to see a lung cancer ad on network TV.”

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ECCO2017 NEWS: The Immunotherapy, Pembrolizumab, Is Active Against Mucosal Melanoma Tumours and Prolongs Survival for Patients with Bladder Cancer

Excerpt:

“Clinical trials of a new immunotherapy, pembrolizumab, have shown that it prolongs life significantly for patients with bladder cancer and is active against a rare sub-type of melanoma, called mucosal melanoma. The findings were presented in two presentations at the European Cancer Congress 2017 today.”

“Until now, mucosal melanoma has often been excluded from immunotherapy treatments for the disease. Melanoma usually occurs in the skin and is caused by exposure to ultraviolet radiation (such as sunlight). Mucosal melanoma occurs in the moist surfaces that line the body’s cavities, such as the airways, digestive tract and genitourinary tracts, and is not caused by UV radiation; there is no known cause. It makes up about one per cent of all melanomas and has a poor prognosis, usually because of late diagnosis – the majority of patients with metastatic disease (cancer that has spread to other parts of the body) survive for less than a year if they have received conventional treatments.”

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Frontline Immunotherapy Combo Setbacks Strike NSCLC

Excerpt:

“Bristol-Myers Squibb (BMS) and AstraZeneca have each announced separate delays in the development of PD-1 and CTLA-4 inhibitor combinations as first-line therapies for patients with advanced or metastatic non–small cell lung cancer (NSCLC), according to statements from each of the companies.

“In its statement, BMS noted that it would not be pursuing an accelerated approval for the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) as a frontline therapy for NSCLC. Instead, the company plans to delay the submission of data to the FDA until findings from a phase III study are available, most likely from the phase III CheckMate-227 trial.”

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Bristol Won’t Seek Faster Opdivo/Yervoy Lung Cancer Approval

Excerpt:

“Bristol-Myers Squibb Co on Thursday said it has decided not to seek accelerated U.S. approval for a combination of its two immunotherapy drugs as an initial treatment for lung cancer.

“Shares of Bristol, which closed at $55.49 on the New York Stock Exchange, were down 6.2 percent at $52.08 after hours.

“The pharmaceutical company cited ‘a review of data available at this time’ for the decision to hold off on filing for Food and Drug Administration approval of the combination of its cancer drugs Opdivo and Yervoy.”

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