OREANDA-NEWS. May 17, 2016. Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that new and updated data investigating KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, in more than 15 types of cancer will be presented at the 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, June 3 – 7, 2016.

At this year’s meeting, researchers will present data from studies of KEYTRUDA as a single agent, and in combination with other therapies, in melanoma and non-small cell lung cancer (NSCLC), as well as bladder, colorectal, esophageal, gastric, head and neck, renal cancers, lymphoma and multiple myeloma. First-time presentation of findings for KEYTRUDA will be presented in new tumor types including cervical, endometrial, leiomyosarcoma, pancreatic, salivary, and thyroid. Several abstracts were chosen to be presented as oral presentations – one of which includes three-year survival data for patients with advanced melanoma (abstract #9503); this abstract will be featured in the official ASCO press program on Wednesday, May 18 at 12:00 p.m. EDT.

“This year’s ASCO annual meeting represents a significant milestone for the KEYTRUDA clinical development program, which now includes more than 270 ongoing or planned studies across more than 30 tumor types, both as a single agent and in combination with other therapies,” said Dr. Roy Baynes, senior vice president and head of global clinical development, Merck Research Laboratories. “We look forward to sharing new data with the cancer community from our industry-leading immuno-oncology program as we seek to advance our shared goal of transforming outcomes for patients across a broad range of tumors.”

KEYTRUDA (pembrolizumab) Data at the 2016 ASCO Annual Meeting

A select list of abstracts and sessions featuring KEYTRUDA data – including oral presentations, clinical science symposia, posters, and poster discussions – are provided below:

Advanced Melanoma: Merck has established a broad data set for KEYTRUDA in the treatment of advanced melanoma. At ASCO, oral presentations supporting the use of KEYTRUDA in the currently approved indication will include three-year overall survival (OS) data from the KEYNOTE-001 trial and a final OS analysis from the KEYNOTE-006 trial. Additionally, new and updated findings building on the growing body of research evaluating KEYTRUDA in combination with other therapies will be presented.

  • (Abstract #9503) Oral Abstract Session: Three-year overall survival for patients with advanced melanoma treated with pembrolizumab in KEYNOTE-001. C. Robert. Monday, June 6. 2:15 p.m. – 2:27 p.m. CDT. Location: Arie Crown Theater.
  • (Abstract #9504) Oral Abstract Session: Pembrolizumab versus ipilimumab for advanced melanoma: Final overall survival analysis of KEYNOTE-006. J. Schachter. Monday, June 6. 2:27 p.m. – 2:39 p.m. CDT. Location: Arie Crown Theater.
  • (Abstract #9506) Oral Abstract Session: Pembrolizumab (pembro) plus ipilimumab (ipi) for advanced melanoma: Results of the KEYNOTE-029 expansion cohort. G. Long. Monday, June 6. 2:51 p.m. – 3:03 p.m. CDT. Location: Arie Crown Theater.
  • (Abstract #9568) Poster Session: Efficacy analysis of MASTERKEY-265 phase 1b study of talimogene laherparepvec (T-VEC) and pembrolizumab (pembro) for unresectable stage IIIB-IV melanoma. G. Long. Saturday, June 4. 1:00 p.m. – 4:30 p.m. CDT. Location: Hall A.
  • (Abstract #3014) Poster Session/Discussion: Pembrolizumab (pembro) in combination with dabrafenib (D) and trametinib (T) for BRAF-mutant advanced melanoma: Phase 1 KEYNOTE-022 study. A. Ribas. Sunday, June 5. Poster: 8:00 a.m. – 11:30 a.m. CDT. Location: Hall A. Discussion: 4:45 p.m. – 6:00 p.m. CDT. Location: Hall B1.

Advanced Lung Cancer: Merck is continuing to advance the understanding of KEYTRUDA in lung cancer as a single agent and in combination with other therapies. Research to be presented at ASCO includes data from the KEYNOTE-010 trial in advanced NSCLC, as well as studies exploring PD-L1 expression, long-term survival, and combination with chemotherapy as a first-line therapy.

  • (Abstract #9026) Poster Session: Long-term OS for patients with advanced NSCLC enrolled in the KEYNOTE-001 study of pembrolizumab (pembro). R Hui. Saturday, June 4. 8:00 a.m. – 11:30 a.m. CDT. Location: Hall A.
  • (Abstract #9024) Poster Session: Pembrolizumab vs docetaxel for previously treated advanced NSCLC with a PD-L1 tumor proportion score (TPS) 1%-49%: Results from KEYNOTE-010. E. Garon. Saturday, June 4. 8:00 a.m. – 11:30 a.m. CDT. Location: Hall A.
  • (Abstract #9015) Poster Session/Discussion: Relationship between level of PD-L1 expression and outcomes in the KEYNOTE-010 study of pembrolizumab vs docetaxel for previously treated, PD-L1-Positive NSCLC. P. Baas. Saturday, June 4. Poster: 8:00 a.m. – 11:30 a.m. CDT. Location: Hall A. Discussion: 3:00 p.m. – 4:15 p.m. CDT. Location: E354b.
  • (Abstract #9016) Poster Session/Discussion: Pembrolizumab (pembro) plus chemotherapy as front-line therapy for advanced NSCLC: KEYNOTE-021 cohorts A-C. S. Gadgeel. Saturday, June 4. Poster: 8:00 a.m. – 11:30 a.m. CDT. Location: Hall A. Discussion: 3:00 p.m. – 4:15 p.m. CDT. Location: E354b.

Advanced Head and Neck Cancer: With multiple registration-enabling studies, Merck currently has the largest immuno-oncology clinical development program in head and neck cancer and is advancing research investigating OS and progression-free survival (PFS) endpoints with single agent KEYTRUDA (pembrolizumab), as well as in combination with chemotherapy compared to standard of care. At ASCO, presentations in this tumor type will include first-time findings from the KEYNOTE-055 trial in head and neck squamous cell carcinoma (HNSCC) and updated findings from the KEYNOTE-012 trial, which was the first clinical study investigating the role of a PD-1 inhibitor in recurrent or metastatic head and neck cancer and served as the basis for the KEYTRUDA supplemental Biologics License Application (sBLA) filing.

  • (Abstract #6012) Clinical Science Symposium: Efficacy and safety of pembrolizumab in recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC): Pooled analyses after long-term follow-up in KEYNOTE-012. R. Mehra. Monday, June 6. 12:18 p.m. – 12:30 p.m. CDT. Location: S100bc.
  • (Abstract #6011) Clinical Science Symposium: Preliminary results from KEYNOTE-055: Pembrolizumab after platinum and cetuximab failure in head and neck squamous cell carcinoma (HNSCC). J. Bauml. Monday, June 6. 12:06 p.m. – 12:18 p.m. CDT. Location: S100bc.
  • (Abstract #6017) Poster Session/Poster Discussion Session: Preliminary results for the advanced salivary gland carcinoma cohort of the phase 1b KEYNOTE-028 study of pembrolizumab. R. Cohen. Saturday, June 4. Poster: 1:00 p.m. – 4:30 p.m. CDT. Location: Hall A. Discussion: 4:45 p.m. – 6:00 p.m. CDT. Location: S406.
  • (Abstract #6010) Clinical Science Symposium: Biomarkers and response to pembrolizumab (pembro) in recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). L. Chow. Monday, June 6. 11:42 a.m. – 11:54 a.m. CDT. Location: S100bc.

Advanced Hematological Cancers: Data in several hematological cancers will be presented at ASCO, including new findings from the KEYNOTE-087 trial evaluating single agent KEYTRUDA (pembrolizumab) in patients with classical Hodgkin lymphoma (cHL), which supported the recent Breakthrough Therapy Designation granted to KEYTRUDA by the U.S. Food and Drug Administration (FDA). A final analysis of the KEYNOTE-023 trial, investigating KEYTRUDA in combination with two commonly used treatments for multiple myeloma, will also be presented.

  • (Abstract #7555) Poster Session/Discussion: Pembrolizumab for relapsed/refractory classical Hodgkin lymphoma (R/R cHL): phase 2 KEYNOTE-087 study. R. Chen. Monday June 6. Poster: 8:00 a.m. – 11:30 a.m. CDT. Location: Hall A. Discussion: 1:15 p.m. – 2:45 p.m. CDT. Location: E345b.
  • (Abstract #8010) Clinical Science Symposium: Pembrolizumab in combination with lenalidomide and low-dose dexamethasone for relapsed/refractory multiple myeloma (RRMM): Final efficacy and safety analysis. M. Mateos. Tuesday, June 7. 10:09 a.m. – 10:21 a.m. CDT. Location: E354b.

Additional Data from Merck’s Oncology Portfolio

Data from studies of other medicines in Merck’s portfolio and pipeline will also be presented at the meeting. For more information, including a complete list of abstract titles, please visit the ASCO website at https://iplanner.asco.org/AM2016/#/.

About KEYTRUDA® (pembrolizumab) Injection 100 mg

KEYTRUDA is a humanized monoclonal antibody that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

KEYTRUDA is also indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 as determined by an FDA-approved test with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA. This indication is approved under accelerated approval based on tumor response rate and durability of response. An improvement in survival or disease-related symptoms has not yet been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

KEYTRUDA is administered at a dose of 2 mg/kg as an intravenous infusion over 30 minutes every three weeks for the approved indications.

Selected Important Safety Information for KEYTRUDA® (pembrolizumab)

Immune-mediated pneumonitis, including fatal cases, occurred in patients receiving KEYTRUDA. Pneumonitis occurred in 32 (2.0%) of 1567 patients with melanoma, including Grade 1 (0.8%), 2 (0.8%), and 3 (0.4%) pneumonitis. Pneumonitis occurred in 19 (3.5%) of 550 patients with NSCLC, including Grade 2 (1.1%), 3 (1.3%), 4 (0.4%), or 5 (0.2%) pneumonitis and more frequently in patients with a history of asthma/chronic obstructive pulmonary disease (5.4%) or prior thoracic radiation (6.0%). Monitor patients for signs and symptoms of pneumonitis. Evaluate suspected pneumonitis with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 or recurrent Grade 2 pneumonitis.

Immune-mediated colitis occurred in 31 (2%) of 1567 patients with melanoma, including Grade 2 (0.5%), 3 (1.1%), and 4 (0.1%) colitis. Immune-mediated colitis occurred in 4 (0.7%) of 550 patients with NSCLC, including Grade 2 (0.2%) or 3 (0.4%) colitis. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA (pembrolizumab) for Grade 2 or 3; permanently discontinue KEYTRUDA for Grade 4 colitis.

Immune-mediated hepatitis occurred in patients receiving KEYTRUDA. Hepatitis occurred in 16 (1%) of 1567 patients with melanoma, including Grade 2 (0.1%), 3 (0.7%), and 4 (0.1%) hepatitis. Monitor patients for changes in liver function. Administer corticosteroids for Grade 2 or greater hepatitis and, based on severity of liver enzyme elevations, withhold or discontinue KEYTRUDA .

Hypophysitis occurred in 13 (0.8%) of 1567 patients with melanoma, including Grade 2 (0.3%), 3 (0.3%), and 4 (0.1%) hypophysitis. Hypophysitis occurred in 1 (0.2 %) of 550 patients with NSCLC, which was Grade 3 in severity. Monitor patients for signs and symptoms of hypophysitis (including hypopituitarism and adrenal insufficiency). Administer corticosteroids and hormone replacement as clinically indicated. Withhold KEYTRUDA for Grade 2; withhold or discontinue for Grade 3 or 4 hypophysitis.

Hyperthyroidism occurred in 51 (3.3%) of 1567 patients with melanoma, including Grade 2 (0.6%) and 3 (0.1%) hyperthyroidism. Hypothyroidism occurred in 127 (8.1%) of 1567 patients with melanoma, including Grade 3 (0.1%) hypothyroidism. Hyperthyroidism occurred in 10 (1.8%) of 550 patients with NSCLC, including Grade 2 (0.7%) or 3 (0.3%) hyperthyroidism. Hypothyroidism occurred in 38 (6.9%) of 550 patients with NSCLC, including Grade 2 (5.5%) or 3 (0.2%) hypothyroidism. Thyroid disorders can occur at any time during treatment. Monitor patients for changes in thyroid function (at the start of treatment, periodically during treatment, and as indicated based on clinical evaluation) and for clinical signs and symptoms of thyroid disorders. Administer replacement hormones for hypothyroidism and manage hyperthyroidism with thionamides and beta-blockers as appropriate. Withhold or discontinue KEYTRUDA for Grade 3 or 4 hyperthyroidism.

Type 1 diabetes mellitus, including diabetic ketoacidosis, occurred in 3 (0.1%) of 2117 patients. Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Administer insulin for type 1 diabetes, and withhold KEYTRUDA and administer anti hyperglycemics in patients with severe hyperglycemia.

Immune-mediated nephritis occurred in patients receiving KEYTRUDA. Nephritis occurred in 7 (0.4%) of 1567 patients with melanoma including, Grade 2 (0.2%), 3 (0.2%), and 4 (0.1%) nephritis. Monitor patients for changes in renal function. Administer corticosteroids for Grade 2 or greater nephritis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA (pembrolizumab) for Grade 3 or 4 nephritis.

Other clinically important immune-mediated adverse reactions can occur. For suspected immune-mediated adverse reactions, ensure adequate evaluation to confirm etiology or exclude other causes. Based on the severity of the adverse reaction, withhold KEYTRUDA and administer corticosteroids. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Based on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immunosuppressants can be considered. Resume KEYTRUDA when the adverse reaction remains at Grade 1 or less following corticosteroid taper. Permanently discontinue KEYTRUDA for any Grade 3 immune-mediated adverse reaction that recurs and for any life-threatening immune-mediated adverse reaction.

The following clinically significant, immune-mediated adverse reactions occurred in less than 1% (unless otherwise indicated) of 1567 patients with melanoma: arthritis (1.6%), exfoliative dermatitis, bullous pemphigoid, uveitis, myositis, Guillain-Barr? syndrome, myasthenia gravis, vasculitis, pancreatitis, hemolytic anemia, and partial seizures arising in a patient with inflammatory foci in brain parenchyma. The following clinically significant, immune-mediated adverse reactions occurred in less than 1% of 550 patients with NSCLC: rash, vasculitis, hemolytic anemia, serum sickness, and myasthenia gravis.

Severe and life-threatening infusion-related reactions have been reported in 3 (0.1%) of 2117 patients. Monitor patients for signs and symptoms of infusion related reactions including rigors, chills, wheezing, pruritus, flushing, rash, hypotension, hypoxemia, and fever. For Grade 3 or 4 reactions, stop infusion and permanently discontinue KEYTRUDA .

Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. If used during pregnancy, or if the patient becomes pregnant during treatment, apprise the patient of the potential hazard to a fetus. Advise females of reproductive potential to use highly effective contraception during treatment and for 4 months after the last dose of KEYTRUDA.

In Trial 6, KEYTRUDA was discontinued due to adverse reactions in 9% of 555 patients with advanced melanoma; adverse reactions leading to discontinuation in more than one patient were colitis (1.4%), autoimmune hepatitis (0.7%), allergic reaction (0.4%), polyneuropathy (0.4%), and cardiac failure (0.4%). Adverse reactions leading to interruption of KEYTRUDA occurred in 21% of patients; the most common (?1%) was diarrhea (2.5%). The most common adverse reactions with KEYTRUDA (pembrolizumab) vs ipilimumab were fatigue (28% vs 28%), diarrhea (26% with KEYTRUDA), rash (24% vs 23%), and nausea (21% with KEYTRUDA). Corresponding incidence rates are listed for ipilimumab only for those adverse reactions that occurred at the same or lower rate than with KEYTRUDA.

In Trial 2, KEYTRUDA was discontinued due to adverse reactions in 12% of 357 patients with advanced melanoma; the most common (?1%) were general physical health deterioration (1%), asthenia (1%), dyspnea (1%), pneumonitis (1%), and generalized edema (1%). Adverse reactions leading to interruption of KEYTRUDA occurred in 14% of patients; the most common (?1%) were dyspnea (1%), diarrhea (1%), and maculo-papular rash (1%). The most common adverse reactions with KEYTRUDA vs chemotherapy were fatigue (43% with KEYTRUDA), pruritus (28% vs 8%), rash (24% vs 8%), constipation (22% vs 20%), nausea (22% with KEYTRUDA), diarrhea (20% vs 20%), and decreased appetite (20% with KEYTRUDA). Corresponding incidence rates are listed for chemotherapy only for those adverse reactions that occurred at the same or lower rate than with KEYTRUDA.

KEYTRUDA was discontinued due to adverse reactions in 14% of 550 patients with NSCLC. Serious adverse reactions occurred in 38% of patients. The most frequent serious adverse reactions reported at least 2% of patients were pleural effusion, pneumonia, dyspnea, pulmonary embolism, and pneumonitis. The most common adverse reactions (reported in at least 20% of patients) were fatigue (44%), cough (29%), decreased appetite (25%), and dyspnea (23%).

No formal pharmacokinetic drug interaction studies have been conducted with KEYTRUDA.

It is not known whether KEYTRUDA is excreted in human milk. Because many drugs are excreted in human milk, instruct women to discontinue nursing during treatment with KEYTRUDA and for 4 months after the final dose.

Safety and effectiveness of KEYTRUDA have not been established in pediatric patients.

Our Focus on Cancer

Our goal is to translate breakthrough science into innovative oncology medicines to help people with cancer worldwide. At Merck Oncology, helping people fight cancer is our passion and supporting accessibility to our cancer medicines is our commitment. Our focus is on pursuing research in immuno-oncology and we are accelerating every step in the journey – from lab to clinic – to potentially bring new hope to people with cancer.

As part of our focus on cancer, Merck is committed to exploring the potential of immuno-oncology with one of the fastest-growing development programs in the industry. We are currently executing an expansive research program that includes more than 270 clinical trials evaluating our anti-PD-1 therapy across more than 30 tumor types. We also continue to strengthen our immuno-oncology portfolio through strategic acquisitions and are prioritizing the development of several promising immunotherapeutic candidates with the potential to improve the treatment of advanced cancers.

For more information about our oncology clinical trials, visit www.merck.com/clinicaltrials.

About Merck

For 125 years, Merck has been a global health care leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook, YouTube and LinkedIn.

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Please see Prescribing Information for KEYTRUDA (pembrolizumab) at http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf and

Patient Information/Medication Guide for KEYTRUDA at http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_mg.pdf.