Claim: Merck wins UK okay for Keytruda in lung cancer after price cut.
Verdict: SUPPORTS

Retrieved passages:
title: Kenneth Frazier
text: first PD-1 antibody called Opdivo, filed the suit against Merck in September 2014, alleging that its sale of Keytruda, also a PD-1 antibody, infringed their patents in markets including the United States, parts of Europe, Australia and Japan. Merck will make an initial payment of $625 million to Bristol and Japan's Ono. The company will also pay a 6.5-percent royalty rate on Keytruda sales from January 2017 to December 2023, and a 2.5-percent rate for the subsequent three years. In the first two months of 2017, sales of Keytruda in the US jumped to roughly $260 million, an 80-percent increase

title: Merck & Co.
text: Merck & Co. announced it would spend $95 million up front on collaborating with cCAM Biotherapeutics and its lead candidate (an early-stage treatment similar to Keytruda). The company is due up to $510 million more, which is tied to clinical, regulatory and commercial milestones. Merck & Co. will bring in CM-24, an antibody designed to block the immune checkpoint CEACAM1. In January 2016 Merck & Co. announced two new partnerships; the first with Quartet Medicine and its small molecule pain treatments, the second with Complix investigating intracellular cancer targets, with both collaborations potentially generating up to $595 million and $280

title: PD-1 and PD-L1 inhibitors
text: PD-L1 drugs in combination with other immunotherapy drugs blocking LAG3, B7-H3, KIR, OX40, PARP, CD27, and ICOS. Pembrolizumab (formerly MK-3475 or lambrolizumab, Keytruda) was developed by Merck and first approved by the Food and Drug Administration in 2014 for the treatment of melanoma. It was later approved for metastatic non-small cell lung cancer and head and neck squamous cell carcinoma. In 2017, it became the first immunotherapy drug approved for use based on the genetic mutations of the tumor rather than the site of the tumor. It was shown, that patients with higher non-synonymous mutation burden in their tumors respond

title: Checkpoint inhibitor
text: Squibb) were published in 2010. It was approved in 2014. Nivolumab is approved to treat melanoma, lung cancer, kidney cancer, bladder cancer, head and neck cancer, and Hodgkin's lymphoma. Pembrolizumab (brand name Keytruda) is another PD1 inhibitor that was approved by the FDA in 2014 and was the second checkpoint inhibitor approved in the United States. Keytruda is approved to treat melanoma and lung cancer and is produced by Merck. Spartalizumab (PDR001) is a PD-1 inhibitor currently being developed by Novartis to treat both solid tumors and lymphomas In May 2016, PD-L1 inhibitor atezolizumab was approved for treating bladder cancer.

title: Merck Group
text: chemicals to the electronics industry. In September 2014 Merck halted the clinical development of two drug candidates in development with Oxygen Biotherapeutics. One drug candidate suffered a lack of success in patient recruitment, with its MUC1 antigen-specific cancer immunotherapy drug, tecemotide (L-BLP25), missing its Phase I/II endpoint of increasing overall survival in patients with Stage III non-small cell lung cancer. Later in September it was announced that the company would acquire Sigma-Aldrich for $17 billion. After the acquisition was completed in 2015, Merck has around 50,000 employees. In November 2014, Merck and Pfizer agreed a deal for the latter to

title: Cetuximab
text: in Israel, challenged the Aventis-owned patent, licensed by Imclone, for the use of anti-epidermal growth factor receptor antibodies in combination with chemotherapy, to slow the growth of certain tumors which was filed in 1989 by Rhone-Poulenc-Rorer. The court ruled that Yeda is sole owner of the patent in the U.S., while Yeda and Sanofi-Aventis co-own the patent's foreign counterparts. Cetuximab is given by intravenous therapy and costs up to $30,000 for eight weeks of treatment per patient. Merck KGaA had 887 million euros ($1.15 billion) in Erbitux sales in 2012, from head and neck as well as bowel cancer, while

title: Tecemotide
text: patients with Stage III non-small cell lung cancer did not meet its primary endpoint of an improvement in overall survival, and no treatment effect was seen in any of the secondary endpoints (progression free survival, time to progression or time to failure). Merck made the recommendation to stop the investigational treatment of patients in the EMR 63325-009 study in Japan. Furthermore, Merck KGaA announced its decision to discontinue the Phase III START2 and INSPIRE studies, and all other Merck-sponsored clinical trials with tecemotide in NSCLC worldwide. Merck will continue to supply tecemotide for ongoing investigator-sponsored trials in other indications in

title: Programmed cell death protein 1
text: a response. Nivolumab (Opdivo, Bristol-Myers Squibb) was approved in Japan in July 2014 and by the US FDA in December 2014 to treat metastatic melanoma. Pembrolizumab (Keytruda, MK-3475, Merck), which also targets PD-1 receptors, was approved by the FDA in Sept 2014 to treat metastatic melanoma. Pembrolizumab has been made accessible to advanced melanoma patients in the UK via UK Early Access to Medicines Scheme (EAMS) in March 2015. It is being used in clinical trials in the US for lung cancer, lymphoma, and mesothelioma. It has had measured success, with little side effects. It is up to the manufacturer

title: Pembrolizumab
text: Pembrolizumab Pembrolizumab (formerly MK-3475 and lambrolizumab, trade name Keytruda) is a humanized antibody used in cancer immunotherapy. It is an IgG4 isotype antibody that blocks a protective mechanism of cancer cells and thereby allows the immune system to destroy them. It targets the programmed cell death 1 (PD-1) receptor of lymphocytes. The FDA initially approved it to treat metastatic melanoma. In 2017 the FDA approved it for any unresectable or metastatic solid tumor with certain genetic anomalies (mismatch repair deficiency or microsatellite instability). This was the first time the FDA approved a cancer drug based on tumor genetics rather than

title: Microsatellite instability
text: May 2017 the FDA made a historic announcement regarding an immunotherapeutic manufactured by Merck with the brand name called Keytruda® (pembrolizumab) (PD-1 inhibitor) was approved for patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed following prior treatment. This indication is independent of PD-L1 expression assessment, tissue type and tumor location. MSI is a good marker for determining Lynch syndrome and determining a prognosis for cancer treatments. In 1996, the National Cancer Institute (NCI) hosted an international workshop on Lynch Syndrome, which led to the development of the “Bethesda Guidelines” and

title: Cancer immunotherapy
text: its primary endpoint for treatment in the first line setting, but is FDA approved in subsequent lines of therapy. Pembrolizumab is another PD1 inhibitor that was approved by the FDA in 2014. Keytruda (Pembrolizumab) is approved to treat melanoma and lung cancer. Antibody BGB-A317 is a PD-1 inhibitor (designed to not bind Fc gamma receptor I) in early clinical trials. In May 2016, PD-L1 inhibitor atezolizumab was approved for treating bladder cancer. Anti-PD-L1 antibodies currently in development include avelumab and durvalumab, in addition to an affimer biotherapeutic. Other modes of enhancing [adoptive] immuno-therapy include targeting so-called intrinsic checkpoint blockades e.g.

title: H. Lee Moffitt Cancer Center & Research Institute
text: Cancer Center conducted a registration trial using the drug manufactured by Genentech, a member of the Roche Group. Dr. Anna Giuliano, director of Moffitt's Center for Infection Research in Cancer, led two studies on human papillomavirus (HPV) infection in men. Her work strengthened the Food & Drug Administration (FDA) recommendation for boys and men to receive HPV vaccinations and provided useful data for the development of realistic cost-effectiveness models for male HPV vaccination internationally. In September 2014, a new cancer immunotherapy for melanoma patients called Keytruda became the first anti-PD-1 (programmed death receptor-1) therapy approved in the United States. Jeffrey

title: Erlotinib
text: Erlotinib Erlotinib hydrochloride (trade name Tarceva) is a drug used to treat non-small cell lung cancer, pancreatic cancer and several other types of cancer. It is a receptor tyrosine kinase inhibitor, which acts on the epidermal growth factor receptor (EGFR). It is marketed in the United States by Genentech and OSI Pharmaceuticals and elsewhere by Roche. In the United States as of 2015 one 150 mg pill costs between 200 and 242 USD. Erlotinib has shown a survival benefit in the treatment of lung cancer in phase III trials. The SATURN (Sequential Tarceva in Unresectable Non-small cell lung cancer) study

title: Pembrolizumab
text: few senior people at Merck with strong experience in lung cancer drug development, but had been promoted to senior management and was no longer involved in product development. He stepped down from his role to lead clinical development of pembrolizumab for lung cancer. Scientists at the company argued for developing a companion diagnostic and limiting testing of the drug only to patients with biomarkers showing they were likely to respond, and received agreement from management. Some people, including shareholders and analysts, criticized this decision as it limited the potential market size for the drug, while others argued it increased the

title: Pembrolizumab
text: mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after two or more prior lines of therapy. Pembrolizumab was priced at $150,000 per year when it launched (late 2014). In 2015, Merck reported results in 13 cancer types; much attention was given to early results in head and neck cancer. As of May 2016, pembrolizumab was in Phase IB clinical trials for triple-negative breast cancer (TNBC), gastric cancer, urothelial cancer, and head and neck cancer (all under the "Keynote-012" trial) and in Phase II trial for TNBC (the "Keynote-086" trial). At ASCO in June 2016, Merck reported that the clinical

title: Saladax Biomedical
text: for patients with non-small cell lung cancer (NSCLC). Results from another large randomized study with the department of Oncology, Shanghai Pulmonary Hospital, Tongji University, Shanghai, China, for paclitaxel in NSCLC, also demonstrated that TDM resulted in reduced toxicity with better progression free survival, lending further support to the utility of TDM in oncology. A study of therapeutic drug monitoring of infusional 5-fluoruracil, a widely used agent in colorectal cancer, was conducted with the CESAR group. This was a prospective multicenter study that demonstrated the utility of 5-FU TDM in routine clinical practice. 5-FU exposure was significantly improved when dosing was

title: Pembrolizumab
text: roughly divided between melanoma and lung cancer. In 2013 Merck quietly applied for and won a breakthrough therapy designation for the drug. This regulatory pathway was new at the time and not well understood. One of its advantages is that the FDA holds more frequent meetings with drug developers, reducing the risk of developers making mistakes or misunderstandings arising between regulators' expectations and what the developers want to do. This was Merck's first use of the designation and the reduction in regulatory risk was one of the reasons management was willing to put company resources into development. In 2013, the

title: Kenneth Frazier
text: attributing the fiasco to "the failed memory of a retired employee." Federal Judge Beth Labson Freeman described the company's behavior as "systematic and outrageous deception in conjunction with unethical business practices and litigation misconduct." That conduct included "lying to Pharmasset, misusing Pharmasset's confidential information, breaching confidentiality and firewall agreements, and lying under oath at deposition and trial." In 2017, Merck & Co said it agreed to enter into a settlement and license agreement with Bristol-Myers Squibb Co and Ono Pharmaceutical Co Ltd to resolve all global patent-infringement litigation related to its cancer drug, Keytruda. Bristol and Ono, which co-developed the

title: Cetuximab
text: Cetuximab Cetuximab is an epidermal growth factor receptor (EGFR) inhibitor used for the treatment of metastatic colorectal cancer, metastatic non-small cell lung cancer and head and neck cancer. Cetuximab is a chimeric (mouse/human) monoclonal antibody given by intravenous infusion that is distributed under the trade name Erbitux in the U.S. and Canada by the drug company Bristol-Myers Squibb and outside those countries by the drug company Merck KGaA. In Japan, Merck KGaA, Bristol-Myers Squibb and Eli Lilly have a co-distribution. In July 2009, the FDA approved cetuximab (Erbitux) for treatment of colon cancer with wild-type KRAS, since it had little

title: PD-1 and PD-L1 inhibitors
text: better to the treatment. Both their objective response rate and progression-free survival was shown to be higher than in patients with low non-synonymous mutation burden. This suggests that tobacco smoking, due to its high carcinogenicity, not only causes promotion of cancer (in case of non-small-cell lung carcinoma), but also increases chances of the immune system to recognize and attack to the tumor. Nivolumab (Opdivo) was developed by Bristol-Myers Squibb and first approved by the FDA in 2014 for the treatment of melanoma. It was later approved for squamous cell lung cancer, renal cell carcinoma, and Hodgkin's lymphoma. As of 2017,