Latest Cancer News

Immunotherapy with Checkpoint Inhibitor Durvalumab Show Promise in Triple Negative Breast Cancer

Doctors from Yale Cancer Center presented new data at the American Society of Clinical Oncology meeting on the impact of combining the immune checkpoint inhibitor (durvalumab/MEDI4736) with chemotherapy as preoperative treatment for early stage triple negative breast cancer (TNBC).  Overall patients with TNBC achieved a 71% pathologic complete response to the combination treatment in the initial clinical trial. By comparison, chemotherapies alone produce a pathologic complete response rate of only around 35-40% for women with TNBC.

About 10% of breast cancers are found to be triple negative, where the breast cancer cells have tested negative for estrogen receptors (ER-), progesterone receptors (PR-), and HER2 (HER2-). It is understood that there is a significant unmet need for new treatment options to increase cure rates for women with TNBC. One approach being evaluated is combining novel precision medicines and immunotherapy with traditional chemotherapy medicines.

About durvalumab (MEDI4736)

Durvalumab is an investigational human monoclonal antibody directed against programmed death ligand-1 (PD-L1). PD-L1 can be expressed by tumors to evade detection by the immune system through binding to PD-1 on cytotoxic T lymphocytes. Durvalumab blocks the PD-L1 interaction with PD-1, countering the tumor’s immune-evading tactics. Durvalumab is being developed, alongside other immunotherapies, to empower the patient’s immune system and attack the cancer.

Durvalumab was given breakthrough therapy designation by the FDA on the basis of early clinical data from a Phase I trial in patients with advanced bladder cancer that had progressed during or after one standard platinum-based regimen. Durvalumab is being evaluated in bladder cancer, breast cancer and a variety of other malignancies.

The phase I part of the Yale clinical trial sought to determine the safety and tolerability of durvalumab in combination with weekly nab-paclitaxel and dose dense doxorubicin/cyclophosphamide, a standard active chemotherapy treatment regimen. Overall the treatment was well tolerated and among the 7 patients in the this early trial, 5 achieved pathologic complete response, 1 had partial response with residual disease, and 1 had extensive residual cancer. This corresponds to a pathologic complete response rate of 71%. A larger confirmatory clinical trial is now open for patient accrual at Yale Cancer Center.

Reference: J Clin Oncol 35, 2017 (suppl; abstr 572).

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Precision Therapy Enasidenib Effective in Treating Acute Myeloid Leukemia

According to early clinical trial results published in the journal Blood, some patients with relapsed or treatment-resistant acute myeloid leukemia may achieve remission with an experimental targeted therapy.

AML is the most lethal of the blood cancers, which together are the third leading cause of cancer deaths in the U.S.; AML is responsible for more than 10,000 deaths each year. Despite advances in treating other blood cancers, the standard of treatment for AML – a combination of toxic chemotherapies – has remained the same for more than 40 years. Overall prognosis remains poor, with a five-year survival rate below 20 percent for patients over age 60.

Up to 15 percent of people with AML have a mutation in the IDH2 gene, which prevents their white blood cells from maturing into neutrophils, an integral part of the body’s immune system. Instead, these white blood cells become leukemia cells.

Unlike standard AML therapies, which aggressively target all white blood cells, the experimental therapy enasidenib inhibits the mutated IDH2 gene, allowing immature white blood cells to naturally mature into neutrophils.

Of the 239 IDH2 mutation positive AML patients included in a clinical trial evaluating enasidenib, 74 percent had treatment-resistant disease with few or no remaining therapy options available. Of those 176 patients, 71 (40.3%) responded to treatment, with 34 (19.3%) achieving a complete remission.

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Overall survival for these patients nearly tripled compared to previous studies evaluating other treatments in this patient population, up from 3.3 months to 9.3 months.

Further trials to assess enasidenib as a frontline therapy, in combination with standard AML treatments, and in treating other mutant IDH2 disorders like myelodysplastic syndrome (MDS) are planned or are ongoing.

Reference:  http://www.bloodjournal.org/content/early/2017/06/05/blood-2017-04-779405?sso-checked=true

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FDA Fast Track Designation Granted To CB-839 For Treatment Of Patients With Renal Cell Carcinoma

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CB-839 in combination with afinitor® (everolimus), for the treatment of patients with metastatic renal cell carcinoma who have received 2 or more prior lines of therapy.  CB-839 is a first-in-class, oral, selective, potent inhibitor of glutaminase being evaluated in Phase 1/2 clinical trials for the treatment of solid tumors including renal cell carcinoma, triple negative breast cancer, non-small cell lung cancer, and melanoma.

“We are pleased that CB-839 has been granted Fast Track designation, demonstrating the FDA’s commitment to facilitate the development and expedite the review of our glutaminase inhibitor as an important new therapy for patients with relapsed renal cell carcinoma,” said Susan Molineaux, PhD, President and Chief Executive Officer of Calithera.  “We look forward to initiating a global randomized trial of CB-839 in combination with afinitor® for the treatment of renal cell carcinoma in the second half of 2017.”

The FDA’s Fast Track designation is designed to facilitate the development and expedite the review of drugs and biologics, to treat serious or life threatening conditions, and to fill an unmet medical need.  Specifically, Fast Track designation facilitates frequent interactions with the FDA review team, including meetings to discuss all aspects of development to support approval, and also provides the opportunity to submit sections of an NDA on a rolling basis as data become available.

About Calithera Biosciences

Calithera Biosciences, Inc. is a clinical-stage pharmaceutical company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer. Calithera’s lead product candidate, CB-839, is an inhibitor of glutaminase. CB-839 takes advantage of the pronounced dependency many cancers have on the nutrient glutamine for growth and survival. It is currently being evaluated in Phase 1/2 clinical trials in combination with standard of care agents. CB-1158 is an investigational immuno-oncology metabolic checkpoint inhibitor designed to target arginase, a critical immunosuppressive enzyme responsible for T-cell suppression by myeloid-derived suppressor cells (MDSCs). Arginase depletes arginine, a nutrient that is critical for the activation, growth and survival of the body’s cancer-fighting immune cells, known as cytotoxic T-cells. CB-1158 is being developed in collaboration with Incyte Corporation and is currently in a Phase I clinical trial.

Reference: https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cber/ucm122932.htm

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With Nearly Three Years of Follow-Up, Keytruda® Continues to have Improved Survival Benefit Compared to Yervoy® in Advanced Melanoma

Keytruda® (pembrolizumab) continues to outperform Yervoy® (ipilimumab) as initial treatment of patients with advanced melanoma. Updated results of the KEYNOTE 006 trial presented at the 2017 annual meeting of the American Society of Clinical Oncology (ASCO) report that Keytruda is now associated with a 30% improvement in survival when used as initial treatment for advanced melanoma.

Melanoma is less common than non-melanoma skin cancer, but tends to be much more aggressive. What makes melanoma so dangerous is that it is more likely than other types of skin cancer to spread (metastasize) to other parts of the body. Melanoma can occur anywhere on the body. The first signs of melanoma may be a mole that changes in appearance, bleeds, or has more than one color or an irregular shape.

Keytruda works by blocking the action of a protein called PD-1. Because PD-1 inhibits certain types of immune responses, drugs that block it may enhance the ability of the immune system to fight cancer. In earlier studies Keytruda has demonstrated anticancer activity in advanced melanoma, including disease that has progressed with other therapy.

A recent Phase III clinical trial known as KEYNOTE-006, has been investigating Keytruda directly compared with Yervoy as first-line treatment of patients with advanced melanoma that can’t be removed with surgery. Yervoy is a monoclonal antibody approved for the treatment of advanced melanoma. It may enhance the immune system’s response against tumor cells and was approved in 2011 for the treatment of melanoma that has spread to other sites or cannot be surgically removed. The 834 patients included in KEYNOTE-006 had no more than one previous systemic therapy (such as chemotherapy or biological agents).

Initial results of KEYNOTE 006 published in 2015 demonstrated that Keytruda was significantly more effective than Yervoy in both progression-free and overall survival. With these outcomes, Keytruda became the first anti-PD-1 therapy to demonstrate a survival advantage compared to the standard of care for the first-line treatment of advanced melanoma. Keytruda appeared so much more effective than Yervoy (and acceptably tolerable and safe) that the study’s independent Data Monitoring Committee has recommended that the KEYNOTE-006 trial be stopped early.

In the longer-term findings presented at ASCO, treatment with Keyturda was associated with a continued 30 percent improvement in survival.  Overall 50 percent of patients treated with Keytruda were alive nearly three years after starting treatment compared to 39 percent of patients treated with Yervoy. In addition, Keytruda nearly doubled the rate of progression-free survival at 33.9 months: 31 percent of patients in the Keyturda group were alive and their disease had not progressed, compared to 14 percent of patients treated with Yervoy.

References:

  1. Merck’s Pivotal KEYNOTE-006 Study in First-Line Treatment for Advanced Melanoma Met Co-Primary Endpoints and Will Be Stopped Early [press release]. Merck website. Available at: http://www.mercknewsroom.com/news-release/oncology-newsroom/mercks-pivotal-keynote-006-study-first-line-treatment-advanced-melano. Accessed April 8, 2015.
  2. http://abstracts.asco.org/199/AbstView_199_187297.html

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Sprycel Effective for Treatment of Pediatric Chronic Myeloid Leukemia

In 2002, the FDA approved the drug Gleevec (imatinib) as a first-line therapy for adults with chronic myeloid leukemia (CML) caused by the fusion gene BCR-ABL, known as the Philadelphia chromosome. The approval dramatically extended the lives of patients with the condition and, in many ways, ushered in the era of molecularly-targeted treatments against cancer. Now worldwide phase II clinical trial results presented at the American Society for Clinical Oncology (ASCO) Annual Meeting 2017 show the promise of the second-generation drug Sprycel® (dasatinib), also aimed at BCR-ABL fusion in CML, in a new population, namely pediatric patients.

Gleevec is the standard initial treatment of newly diagnosed chronic myeloid leukemia (CML). Imatinib produces high rates of complete cytogenetic responses (70% to 85%) and of major molecular responses (20% to 40%) and has improved progression-free and overall survival.1 2 However, Gleevec does not eradicate the BCR-ABL clones in most patients as detected by polymerase chain reaction (PCR) monitoring. Furthermore, a small but significant fraction of patients will develop Gleevec-resistance or are intolerant to the drug. Patients who fail or are intolerant to Gleevec now have treatment alternatives other than allogeneic stem cell transplantation.  Chronic myeloid leukemia makes up about 5 percent of all childhood leukemias, resulting in about 150 cases per year in the United States.

Sprycel was developed for the treatment of patients with BCR-ABL-positive CML and acute lymphoblastic leukemia (ALL) and is approved by the US Food and Drug Administration for treatment of patients who fail or are intolerant to Gleeved.

The current study evaluated 113 pediatric patients and is the largest prospective trial of pediatric patients with CML, offered at 80 medical centers in 18 countries.

Overall 75% of these patients who had previously failed or did not tolerate Gleevec saw improved progression-free survival 48 months after starting treatment with Sprycel. Of newly diagnosed pediatric patients who were previously untreated more than 90% saw progression-free survival at 48 months of beginning Sprycel treatment. In addition to the ability of Sprycel to control CML, it appeared to work very quickly.  Within 3 months of beginning Sprycel treatment more than 50% of patients who had previously failed Gleevec responded to treatment.

Reference: http://abstracts.asco.org/199/AbstView_199_181598.html

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Alecensa Superior to Xalkori in Treatment of Lung Cancer

Alecensa (alectinib) halted the spread of lung cancer for a median of 15 months longer than treatment with rival Xalkori (crizotinib) with fewer side effects, according to trial results presented at the 2017 American Society of Clinical Oncology annual meeting in Chicago.

Both drugs are designed to treat advanced non-small cell lung cancer (NSCLC) in patients with a mutation of the ALK gene, which is found in about 5 percent of all NSCLC patients.

About 12,500 Americans are diagnosed with ALK-positive NSCLC each year, according to the American Society of Clinical Oncology, which featured the study results at its annual meeting in Chicago.

Alecensa, is currently approved for people with advanced ALK-positive NSCLC that worsens despite treatment with Xalkori, which is approved as an initial treatment.

The 303-patient clinical trial found that Alecensa reduced the risk of cancer progression or death by 53 percent compared with Xalkori. Patients on Alcensa lived for a median of 25.7 months before their cancer worsened, compared with 10.4 months with Xalkori.

Researchers further reported that cancer spread to the brain for just 9 percent of Alecensa patients, compared with 41 percent of the Xalkori group.

The study establishes Alcensa as the new standard of care for initial treatment in NSCLC. Further studies will evaluate whether other drugs combined with Alcensa can further improve outcomes.

Reference: http://abstracts.asco.org/199/AbstView_199_185951.html

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FDA Expands use of Zykadia® in First-Line ALK-Positive Non-Small Cell Lung Cancer

The US Food and Drug Administration (FDA) approved the expanded use of Zykadia® (ceritinib) to include the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose cancers are anaplastic lymphoma kinase (ALK)-positive, as detected by an FDA-approved test.

About Zykadia

Zykadia is an oral, selective inhibitor of ALK, a gene that can fuse with others to form an abnormal “fusion protein” that promotes the development and growth of certain tumors in cancers including NSCLC. Zykadia is currently approved in over 69 countries worldwide. Approximately 3-7% of all patients with NSCLC have an ALK gene rearrangement.2

The approval of Zykadia is based on results from the ASCEND-4 clinical trial. The study demonstrated that patients treated with first-line Zykadia had an average progression-free survival (PFS) of 16.6 months compared to 8.1 months  for patients treated with standard first-line pemetrexed-platinum chemotherapy and pemetrexed maintenance.1,3

Overall intracranial response rate in patients with measurable brain metastases was 57% for patients treated with Zykadia, versus 22% for patients treated with chemotherapy.

About ASCEND-4

ASCEND-4 is a comparative global clinical trial to Zykadia compared to standard chemotherapy, including maintenance, in adult patients with Stage IIIB or IV ALK-positive advanced NSCLC who received no prior therapy for their advanced disease. Patients received Zykadia orally or standard pemetrexed-based platinum doublet chemotherapy followed by pemetrexed maintenance and were directly compared.

Of 376 patients, 189 (59 with brain metastases) were treated with Zykadia and 187 (62 with brain metastases) with chemotherapy.  Patients treated with first-line Zykadia had a median time to cancer progression of 16.6 months, compared to 8.1 months for patients treated with standard first-line pemetrexed-platinum chemotherapy with pemetrexed maintenance.  Patients without brain metastases receiving Zykadia experienced an average time to cancer progression of 26.3 months compared with 8.3 months among patients treated with chemotherapy. 

References

  1. Zykadia® (ceritinib) Full Prescribing Information.
  2. Lovly, C., L. Horn, W. Pao. 2016. Molecular Profiling of Lung Cancer. My Cancer Genome. https://www.mycancergenome.org/content/disease/lung-cancer/. (Updated March 28). Accessed March 22, 2017.
  3. Soria JC, et al. First-line ceritinib versus platinum-based chemotherapy in advanced ALK-rearranged non-small-cell lung cancer (ASCEND-4): A randomized, open-label Phase 3 study. The Lancet. 2017; 389(10072):917-929.

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Shows Improved Outcomes with Addition of Keytruda® in Triple Negative High-Risk Breast Cancer

The results from the I-SPY 2 TRIAL investigating Keyytruda (pembrolizumab), in combination with standard therapy as a pre-operative (neoadjuvant) treatment for patients with locally advanced breast cancer were released at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.  The estimated pathologic complete response (pCR) rate increased nearly threefold in patients with triple-negative breast cancer (TNBC).

Approximately 12% of all breast cancers are TNBC, meaning that they are estrogen-receptor negative (ER-), progesterone-receptor negative (PR-), and human epidermal growth factor receptor 2-negative (HER2-). This means that TNBC is not stimulated to grow from exposure to the female hormones estrogen or progesterone, nor through an overactive HER2 pathway.

Unfortunately, many available and effective treatment options for the majority of breast cancers block the growth stimulating effects of ER, PR and/or HER2; therefore, TNBC has had limited therapeutic options.

In addition, TNBC tends to be an aggressive type of cancer, is often diagnosed at a more advanced stage, and proportionately affects younger women more often than other breast cancers. Novel treatment options for TNBC have lagged behind that of other types of breast cancers.

The cancer immunotherapy strategy known as programmed cell death 1 (PD-1) has generated great excitement for its ability to help the immune system recognize, and attack cancer. PD-1 is a protein that inhibits certain types of immune responses. Drugs that block PD-1 are called checkpoint inhibitors and may enhance the ability of the immune system to fight cancer.  Keytruda is a fully humanized monoclonal antibody that binds with high-affinity to the PD-1 receptor.

Clinical evidence to date in other cancers is impressive and suggests that Keytruda® and other checkpoint inhibitors such Opdivo (nivolumab), and Yervoy® (ipilimumab) are very effective in melanoma, lymphoma and lung cancer.2-5

The I-SPY 2 clinical trial, sponsored by Quantum Leap Healthcare Collaborative, is a standing Phase 2 clinical trial for women with newly diagnosed, locally advanced breast cancer (Stage II/III), and is designed to screen promising new treatments and identify which therapies are most effective in specific patient subgroups based on molecular characteristics (biomarker signatures).

The trial is an adaptive study design assessing the combination of biologically targeted investigational drugs with standard chemotherapy in the neoadjuvant setting, compared to standard chemotherapy alone. The primary endpoint is to determine whether the combination of certain therapies increases the probability of pCR in the breast and the lymph nodes at the time of surgery.

In the trial patients were treated with standard weekly chemotherapy; paclitaxel for 12 weeks, combined with or without Keytruda, followed by doxorubicin and cyclophosphamide (AC) every 3 weeks for four cycles. Currently 69 patients were treated with Keytruda and 46 have undergone surgery, while the other 23 had an on-therapy MRI assessment or response to treatment.

Overall patients with TNBC had an estimated pCR of 60%.  All HER2 negative patients had a response rate of 46% and HER2 negative hormone receptor positive patients had a response rate of 34%.

Individuals with TNBC achieved an absolute increase in the estimated response of 40% with the addition of Keytruda over the historical experience of 20% with standard therapy alone.

Keytruda in combination with standard therapy tripled the rate of pathologic complete responses in HER2- patients The regimen indicates a new and important treatment pathway and gives us well-grounded hope for new options for patients with these aggressive breast cancers – and that’s potentially very good news.

References:

  1. http://abstracts.asco.org/199/AbstView_199_194235.html
  2. [1] Robert C, Long GV, Brady B, et al. Nivolumab in Previously Untreated Melanoma without BRAF Mutation. New England Journal of Medicine [early online publication]. November 16, 2014.
  3. [2] Topalian SL, Sznol M, McDermott DF, et al. Survival, Durable Tumor Remission, and Long-Term Safety in Patients With Advanced Melanoma Receiving Nivolumab. Journal of Clinical Oncology [early online publication]. March 3, 2014. doi: 10.1200/JCO.2013.53.0105.
  4. [3] Study Comparing Opdivo (nivolumab) to Chemotherapy in Treatment Naïve Advanced Melanoma Patients Marks First PD-1 Immune Checkpoint Inhibitor to Demonstrate a Survival Benefit in a Phase 3 Trial [press release]. Bristol-Myers Squibb website. Available at: http://news.bms.com/press-release/study-comparing-opdivo-nivolumab-chemotherapy-treatment-naive-advanced-melanoma-patien&t=635517264951231587.
  5. Ansell S, Lesokhin A, Borrello I, et al. PD-1 Blockade with Nivolumab in Relapsed or Refractory Hodgkin’s Lymphoma. The New England Journal of Medicine. December 6, 2014DOI: 10.1056/NEJMoa1411087

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Abiraterone Delays Metastatic Prostate Cancer Growth by 18 Months, Extends Survival

Adding Zytiga (abiraterone acetate) plus prednisone to standard hormonal therapy for men with newly diagnosed, metastatic prostate cancer lowers the chance of death by 38%, and more than doubled the median time until the cancer worsened, from 14.8 months to 33 months according to the results of a clinical study featured at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting.

Current treatment options for prostate cancer include watchful waiting, surgery, chemotherapy, radiation, or hormonal therapy. Hormonal therapy is designed to block testosterone from stimulating the growth of hormone-dependent types of prostate cancer. Some hormonal therapies (such as surgical removal of the testes or use of medications such as leuteinizing hormone releasing hormone [LHRH] analogues) inhibit production of testosterone by the testes. Other therapies, such as the antiandrogen drugs, block the activity of testosterone.

Zytiga is an oral drug that blocks the production of androgens (male hormones such as testosterone) not only by the testes but also by the adrenal glands and is effective in the treatment of advanced hormone refractory prostate cancer.

About the Study

The LATITUDE clinical study treated men with newly diagnosed, high-risk metastatic prostate cancer who had not previously received androgen deprivation therapy (ADT). All patients had at least two of three risk factors: Gleason score (a measure of tumor grade) of 8 or more, 3 or more bone metastases, or 3 or more visceral metastases (spread to other organs in certain areas of the body, such as the liver).  Individuals were treated with ADT plus Zytiga and prednisone, or ADT alone and directly compared.

Results of the clinical study revealed that men who received Zytiga had a 38% lower risk of death, a 53% lower risk of the cancer worsening, and cancer growth was delayed by an average of 18.2 months.
Metastatic prostate cancer has been treated the same way for over 50 years until Taxotere (docetaxel) chemotherapy was shown to improve survival in 2015.  Zytiga may be the next advance in treatment with the potential to further improve outcomes by combining it with Taxotere.  .

Reference:  http://abstracts.asco.org/199/AbstView_199_181729.html

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Targeted Therapies Show Initial Effectiveness in Subset of Papillary Thyroid Cancer

Two immunotherapy drugs currently approved by the U.S. Food and Drug Administration (FDA) for the treatment of melanoma also show promise for treating a rare but aggressive form of papillary thyroid cancer.

Up to 44 percent of papillary thyroid cancer patients have a B-raf mutation that can be specifically targeted by existing cancer drugs.

The B-raf gene belongs to a class of genes known as “oncogenes,” which send signals to normal cells that cause them become cancerous. B-raf gene mutations have known roles in the development of many human cancers including melanoma, lung and thyroid cancer.

In a randomized, phase 2 multi-center clinical study let by doctors at The Ohio State James Cancer Institute tested the effectiveness of the targeted therapy drug, Tafinlar given alone compared with the same drug given in combination with MeKinist to treat a subset of advanced papillary thyroid cancer patients with B-raf mutations.

Initial data shows that both Tafinlar alone and combined Tafinlar / MeKinist therapy are well tolerated by patients, resulting in a 50 to 54 percent response rate among the patients advanced BRAF-mutated papillary thyroid cancer participating in the trial.

“This is an entirely new approach to treating a disease that has limited treatment options. There is no clear ‘winner’ between single- and dual-agent targeted therapy yet but the good news is that both therapy approaches resulted in positive outcomes for patients, and that gives us more treatment options to help patients with this disease,” says Shah, a medical oncologist and researcher with the OSUCCC – James Translational Therapeutics Research Program. “Targeted therapy has the potential to change the standard of care for patients affected by this rare but aggressive form of thyroid cancer.”

Researchers will continue to follow patients on this trial to determine if Tafinlar alone or Tafinlar given in combination with MeKinist is more effective long term.

Study Design and Methods

For this study oncologists recruited 53 patients with progressive B-raf-mutated progressive papillary thyroid cancer. Patient median age was 63 and all received treatment at Ohio State, Massachusetts General Hospital, MD Anderson, University of California – San Diego or University of Chicago. Patients were randomized to receive twice daily Tafinlar alone or Tafinlar given in combination with once-a-day MeKinist. All drugs are administered orally. Patients who experienced disease progression on Tafinlar alone were able to cross over into the combination treatment arm.

Reference: http://abstracts.asco.org/199/AbstView_199_187228.html

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