On September 1, 2015 Heat Biologics, Inc. (NASDAQ: HTBX), a clinical stage cancer immunotherapy company, reported that it has enrolled the first patient in a Phase 1b clinical trial investigating the combination of its HS-110 therapeutic vaccine and the Bristol-Myers Squibb PD-1 inhibitor nivolumab (Opdivo) in non-small cell lung cancer (NSCLC) (Filing, 8-K, Heat Biologics, SEP 1, 2015, View Source [SID:1234507369]). HS-110 is the Company’s first product candidate in a series of proprietary ImPACT based immunotherapies designed to stimulate patient’s own T-cells to attack cancer. Additionally, as the FDA approval of nivolumab and anticipated approval of other checkpoint inhibitors is dramatically changing the standard of care in lung cancer treatment, Heat is winding down its ongoing Phase 2 trial with HS-110, which does not include a checkpoint inhibitor combination, to instead focus on combinations with checkpoint inhibitors.

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This multicenter trial is evaluating the safety and efficacy of HS-110 in combination with nivolumab in patients with NSCLC whose cancers have progressed after first-line therapy. Primary and secondary trial endpoints include safety and tolerability, immune response, overall response rate and progression-free survival.

"Checkpoint inhibitors such as nivolumab are rapidly becoming standard of care in the treatment of NSCLC and many other types of cancer," stated Jeff Wolf, CEO of Heat Biologics. "Substantial evidence is emerging regarding the benefits of combining checkpoint inhibitors and therapeutic vaccines. Heat had previously reported synergy between ImPACT and anti-PD-1 therapy. This important clinical study is among the first trials to explore the combination of a checkpoint inhibitor and therapeutic vaccine in NSCLC and will enable us to more fully evaluate this combination with other checkpoint inhibitors, such as Merck’s pembrolizumab, as they become available."

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"We reported earlier this year, in a clinical trial for HS-410 for bladder cancer, that patients with low levels of tumor-infiltrating lymphocytes (TILs) at baseline appeared to respond better," said Taylor Schreiber, M.D., Ph.D., Heat’s Chief Scientific Officer. "This is consistent with emerging clinical evidence demonstrating that while responses to checkpoint inhibitor therapy are biased toward patients with pre-existing TILs, the optimal patient population for therapeutic vaccines in conjunction with checkpoint inhibitors may in fact be the checkpoint unresponsive (and TIL negative) population. Currently, only 20% to 30% of NSCLC patients respond to nivolumab. This trial will specifically investigate whether HS-110 can broaden the base of patients who respond to nivolumab and other checkpoint inhibitors."

"This trial is expected to initially enroll 18 patients, and is designed to accommodate rapid cohort expansion as positive clinical data emerge," stated Melissa Price, Ph.D., Heat’s VP of Product Development. "We will be working with Yale Cancer Center’s Translational Immuno-Oncology Laboratory on the analysis of the TILs biomarker data for patient selection. We expect to release top-line objective response rate and 6-month progression free survival (PFS) data on these first 18 patients by the end of 2016, which should enable us to reach a clinical readout for HS-110 with a checkpoint-focused clinical trial, on the same schedule that we had forecasted for our previous trial. Our expectations around the timing of an HS-110 registration-directed study in NSCLC remain unchanged."

Nivolumab (Opdivo) was approved by the US Food and Drug Administration (FDA) for the treatment of NSCLC in March 2015 and is marketed by Bristol-Myers Squibb. Another anti-PD-1 drug candidate, Merck’s pembrolizumab (KEYTRUDA) is currently under FDA Priority Review for NSCLC.

On September 1, 2015 Novartis reported that the European Commission has approved the combination of Tafinlar (dabrafenib) and Mekinist (trametinib) for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation (Press release, Novartis, SEP 1, 2015, https://www.novartis.com/news/media-releases/novartis-receives-eu-approval-tafinlar%C2%AE-and-mekinist%C2%AE-first-combination-approved [SID:1234507367]). This is the first targeted therapy combination approved in the EU to treat patients with the most aggressive form of skin cancer[1], demonstrating improved overall survival versus the current standard of care with BRAF inhibitor monotherapy in two Phase III studies[2,3].

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"We look forward to making the Tafinlar and Mekinist targeted combination treatment, which demonstrated a significant overall survival benefit in two robust clinical trials, available across Europe as soon as possible," said Bruno Strigini, President, Novartis Oncology. "Today’s EU approval further demonstrates our ongoing commitment to deliver medicines that can further enhance outcomes for patients with metastatic melanoma."

Metastatic melanoma is the most serious and life-threatening type of skin cancer[4] and is associated with low survival rates[1]; approximately one out of every five people will survive for five years following a diagnosis with late-stage disease[1]. There are about 200,000 new cases of melanoma diagnosed worldwide each year[5], approximately half of which have BRAF mutations[1,6]. Gene tests can determine whether a tumor has a BRAF mutation, and results can play a key role in prognosis and determining appropriate treatment[1].

Marketing authorization is based on results from the Phase III COMBI-d and COMBI-v studies, in which the Tafinlar/Mekinist combination demonstrated overall survival (OS) benefit compared to Tafinlar and Zelboraf monotherapies respectively in patients with BRAF V600 mutation-positive unresectable or metastatic melanoma[2,3].

The COMBI-d study showed that the combination of Tafinlar and Mekinist achieved a statistically significant OS benefit compared to Tafinlar monotherapy (median of 25.1 months vs 18.7 months; Hazard Ratio [HR] 0.71 [95% Confidence Interval (CI), 0.55-0.92], p=0.011). In those who received Tafinlar in combination with Mekinist, OS was 74% at 1 year and 51% at 2 years versus 68% and 42% for those who received Tafinlar only, respectively. Safety results from the COMBI-d study were consistent with the profile observed to date for the combination; no new safety concerns were observed. The most common adverse events (>=20%) in the combination arm were pyrexia, fatigue, nausea, headache, chills, diarrhea, rash, joint pain (arthralgia), hypertension, vomiting, cough, and peripheral edema[2]. Adverse events or toxicities were generally manageable with appropriate intervention, as described in the product labelling submitted with the application. Updated results from COMBI-v will be presented at an upcoming medical congress.

The European Commission approval applies to all 28 EU member states, plus Iceland, Norway and Liechtenstein.

In the US, the Food and Drug Administration (FDA) granted priority review in July 2015 for regular approval of the Tafinlar and Mekinist combination in BRAF V600 mutation-positive metastatic melanoma. Since January 2014, the combination of Tafinlar and Mekinist has been approved for use in the US in patients with BRAF V600E/K mutation-positive unresectable or metastatic melanoma as detected by an FDA-approved test. The combination was approved through the FDA’s Accelerated Approval program and reviewed under a priority review designation. The approval was contingent on the results of the COMBI-d study, which was designed to evaluate the clinical benefit of the combination in patients with unresectable or metastatic melanoma with a BRAF V600 mutation.

About the COMBI-d Study
COMBI-d is a pivotal Phase III, randomized, double-blinded study comparing the combination of the BRAF inhibitor, Tafinlar, and the MEK inhibitor, Mekinist, to single agent therapy with Tafinlar and placebo in patients with unresectable (Stage IIIC) or metastatic (Stage IV) BRAF V600E/K mutation-positive cutaneous melanoma. The study randomized 423 patients at investigative sites in Australia, Europe and North and South America. The primary endpoint of this study was investigator-assessed progression-free survival (PFS). Secondary endpoints included overall survival (OS), overall response rate (ORR), duration of response (DoR), and safety. There was no crossover between treatment arms[2].

Updated results from the COMBI-d study showed that the combination of Tafinlar and Mekinist achieved a statistically significant OS benefit compared to Tafinlar monotherapy (median of 25.1 months vs 18.7 months; HR 0.71 [95% CI, 0.55-0.92], p=0.011). In those who received the Tafinlar and Mekinist combination, OS was 74% at 1 year and 51% at 2 years versus 68% and 42% for those who received Tafinlar only, respectively. The analysis for the combination also showed median PFS of 11.0 months, ORR of 69%, and median DoR of 12.9 months. The safety results were consistent with the profile observed to date for the combination and consistent with the profile observed for Tafinlar monotherapy; no new safety concerns were observed. The most common adverse events (>=20%) in the combination arm were pyrexia, fatigue, nausea, headache, chills, diarrhea, rash, joint pain (arthralgia), hypertension, vomiting, cough, and peripheral edema. More patients had AEs leading to dose modifications in the combination arm compared to Tafinlar monotherapy. Increased incidence (57% vs 33%) and severity (grade 3, 7% (n=15) vs 2% (n=4)) of pyrexia occurred with combination treatment as compared to Tafinlar monotherapy. There was a lower incidence of cutaneous squamous cell carcinoma (cuSCC) including keratoacanthoma with the combination arm (3% (n=6)) compared to the Tafinlar monotherapy arm (10% (n=22)). Discontinuation of treatment due to adverse events occurred in 11% (n=24) vs 7% (n=14) of patients in the combination group and the monotherapy group, respectively[2].

About the COMBI-v Study
COMBI-v was a two-arm, open-label, Phase III study comparing the combination of Tafinlar and Mekinist combination therapy with vemurafenib monotherapy in patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. The primary endpoint of this study was OS[3]. Updated results from COMBI-v will be presented at an upcoming medical congress.

About Tafinlar and Mekinist Combination
Combination use of Tafinlar and Mekinist in patients with unresectable or metastatic melanoma who have BRAF V600E/K mutation is approved in the US, Australia, Canada and additional countries.

Tafinlar and Mekinist target different kinases within the serine/threonine kinase family – BRAF and MEK1/2, respectively – in the RAS/RAF/MEK/ERK pathway, which is implicated in NSCLC and melanoma, among other cancers. When Tafinlar is used with Mekinist, the combination has been shown to slow tumor growth more effectively compared with either drug alone. The combination of Tafinlar and Mekinist is currently being investigated in an ongoing clinical trial program across a range of tumor types conducted in study centers worldwide.

In 2015, as part of its purchase of oncology products from GlaxoSmithKline, Novartis obtained the worldwide exclusive rights granted by Japan Tobacco Inc. (JT) to develop, manufacture, and commercialize trametinib. JT retains co-promotion rights in Japan.

The safety and efficacy profile of the Tafinlar and Mekinist combination has not yet been established outside the approved indication.

Tafinlar and Mekinist are also indicated as single agents to treat patients with unresectable or metastatic melanoma with a BRAF V600 mutation in more than 35 countries worldwide, including the US and EU.

Tafinlar and Mekinist Combination Important Safety Information for Metastatic Melanoma
Tafinlar and Mekinist combination may cause serious side effects, such as:

When Tafinlar is used in combination with Mekinist, or when Tafinlar is administered as monotherapy, it can cause new cancers (both skin cancer and non-skin cancer). Patients should be advised to contact their doctor immediately for any new lesions, changes to existing lesions on their skin, or signs and symptoms of other malignancies.

Before taking Tafinlar in combination with Mekinist, doctors should test their patients for BRAF wild-type melanoma, as patients without BRAF mutation and with RAS mutation can be at risk of increased cell proliferation in the presence of a BRAF inhibitor.

When Tafinlar is used in combination with Mekinist, it can increase the incidence and severity of bleeding, and in some cases can lead to death. Patients should be advised to call their healthcare provider and get medical help right away if they have headaches, dizziness, or feel weak, cough up blood or blood clots, vomit blood or their vomit looks like "coffee grounds," have red or black stools that look like tar, or any unusual signs of bleeding.

Tafinlar, in combination with Mekinist, can cause blood clots in the arms or legs, which can travel to the lungs and can lead to death. Patients should be advised to get medical help right away if they have the following symptoms: chest pain, sudden shortness of breath or trouble breathing, pain in their legs with or without swelling, swelling in their arms or legs, or a cool or pale arm or leg.

Tafinlar in combination with Mekinist can cause heart problems, including heart failure. A patient’s heart function should be checked before and during treatment. Patients should be advised to call their healthcare provider right away if they have any of the following signs and symptoms of a heart problem: feeling like their heart is pounding or racing, shortness of breath, swelling of their ankles and feet, or feeling lightheaded.

Tafinlar alone, or in combination with Mekinist, can cause severe eye problems that can lead to blindness. Patients should be advised to call their healthcare provider right away if they get these symptoms of eye problems: blurred vision, loss of vision, or other vision changes, seeing color dots, halo (seeing blurred outline around objects), eye pain, swelling, or redness.

Patients should notify their doctor if they experience any new or worsening symptoms of lung or breathing problems, including shortness of breath or cough.

Tafinlar alone or in combination with Mekinist can cause fever, which may be serious. When taking Tafinlar in combination with Mekinist, fever may happen more often or may be more severe. In some cases, chills or shaking chills, too much fluid loss (dehydration), low blood pressure, dizziness, or kidney problems may happen with the fever. Patients should be advised to call their healthcare provider right away if they get a fever above 38.5oC (101.3oF) while taking Tafinlar.

Rash is a common side effect of Tafinlar alone, or when used in combination with Mekinist. Tafinlar alone, or in combination with Mekinist, can also cause other skin reactions. In some cases these rashes and other skin reactions can be severe, and may need to be treated in a hospital. Patients should be advised to call their healthcare provider if they get any of the following symptoms: skin rash that bothers them or does not go away, acne, redness, swelling, peeling, or tenderness of hands or feet, skin redness.

Some people may develop high blood sugar or worsening diabetes during treatment with Tafinlar, alone or in combination with Mekinist. For patients who are diabetic, their healthcare provider should check their blood sugar levels closely during treatment. Their diabetes medicine may need to be changed. Patients should be advised to tell their healthcare provider if they have any of the following symptoms of severe high blood sugar: increased thirst or urinating more often than normal, or urinating an increased amount of urine.

Tafinlar may cause healthy red blood cells to break down too early in people with G6PD deficiency. This may lead to a type of anemia called hemolytic anemia where the body does not have enough healthy red blood cells. Patients should be advised to tell their healthcare provider if they have any of the following signs or symptoms of anemia or breakdown of red blood cells: yellow skin (jaundice), weakness or dizziness, or shortness of breath.

Tafinlar and Mekinist both can cause harm to an unborn baby when taken by a pregnant woman. Tafinlar can also render hormonal contraceptives ineffective.

The most common side effects of Tafinlar and Mekinist combination include fever, nausea, tiredness, rash, chills, diarrhea, headache, vomiting, hypertension, joint pain, peripheral edema and cough. The incidence and severity of fever is increased when Mekinist is used in combination with Tafinlar.

Patients should tell their doctor of any side effect that bothers them or does not go away. These are not all of the possible side effects of Tafinlar and Mekinist combination. For more information, patients should ask their doctor or pharmacist.

Patients should take Tafinlar and Mekinist combination exactly as their health care provider tells them. Patients should not change their dose or stop taking Tafinlar and Mekinist combination unless their health care provider advises them to. Mekinist should be taken only once daily (either in the morning or evening, at the same time as Tafinlar). The first and second dose of Tafinlar should be taken approximately 12 hours apart. Patients should take Tafinlar and Mekinist at least 1 hour before or 2 hours after a meal. Do not take a missed dose of Tafinlar within 6 hours of the next dose of Tafinlar. Do not open, crush, or break Tafinlar capsules. Do not take a missed dose of Mekinist within 12 hours of the next dose of Mekinist.

On September 1, 2015 Bristol-Myers Squibb Company (NYSE:BMY) and AbbVie (NYSE:ABBV) reported the U.S. Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for Empliciti (elotuzumab), an investigational Signaling Lymphocyte Activation Molecule (SLAMF7)-directed immunostimulatory antibody, for the treatment of multiple myeloma as combination therapy in patients who have received one or more prior therapies (Press release, Bristol-Myers Squibb, SEP 1, 2015, View Source [SID:1234507365]). Empliciti was previously granted Breakthrough Therapy Designation, which according to the FDA, is intended to expedite the development and review of drugs for serious or life-threatening conditions. The European Medicines Agency (EMA) also recently validated for review the Marketing Authorization Application for Empliciti, granting it accelerated assessment.

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Bristol-Myers Squibb has proposed the name Empliciti which, if approved by health authorities, will serve as the brand name for elotuzumab.

"Bristol-Myers Squibb is delighted by the approach both agencies have taken to review the Empliciti applications as it underscores the unmet medical need in the treatment of multiple myeloma and the role Immuno-Oncology may play," said Michael Giordano, M.D., senior vice president, Head of Oncology Development, Bristol-Myers Squibb. "The acceptance of our applications by the FDA and EMA brings Bristol-Myers Squibb’s Immuno-Oncology science a step closer to helping patients with hematologic malignancies."

The filing acceptance is primarily supported by data from the ELOQUENT-2 trial, a Phase 3, randomized, open-label study, which evaluated Empliciti in combination with lenalidomide and dexamethasone versus lenalidomide and dexamethasone alone. The results of this trial were published in The New England Journal of Medicine on June 2. Additionally, the filing was supported by data from study CA204-009, a Phase 2, randomized, open-label study which evaluated Empliciti with bortezomib and dexamethasone versus bortezomib and dexamethasone alone. These Phase 2 results were presented in an oral session (Abstract #S103) at the 20th Congress of the European Hematology Association (EHA) (Free EHA Whitepaper).

"AbbVie is encouraged by the FDA’s decision to award priority review to this application," said Gary Gordon, M.D., vice president, oncology clinical development, AbbVie. "AbbVie is committed to the development of novel treatment options for people affected by cancer."

About Empliciti

Bristol-Myers Squibb has proposed the name Empliciti which, if approved by health authorities, will serve as the brand name for elotuzumab. Elotuzumab is an investigational immunostimulatory antibody targeted against SLAMF7, a cell-surface glycoprotein that is highly and uniformly expressed on myeloma cells and Natural Killer (NK) cells, but is not detected on normal solid tissues or on hematopoietic stem cells. The safety and efficacy of elotuzumab have not been evaluated by the FDA or any other health authority.

Bristol-Myers Squibb and AbbVie are co-developing elotuzumab, with Bristol-Myers Squibb solely responsible for commercial activities.

About Multiple Myeloma

Multiple myeloma is a hematologic, or blood, cancer that develops in the bone marrow. It occurs when a plasma cell, a type of cell in the soft center of bone marrow, becomes cancerous and multiplies uncontrollably. Despite advances in multiple myeloma treatment over the last decade, it remains a largely incurable disease with only 45% of patients surviving five years after diagnosis. A common characteristic for many patients is that they experience a cycle of remission and relapse, in which they stop treatment for a short time, but eventually return to a treatment shortly after. Following relapse, less than 20% of patients are alive after five years. It is estimated that annually more than 114,200 new cases of multiple myeloma are diagnosed globally and annually more than 79,000 people die from the disease globally.

On September 1, 2015 Adaptimmune Therapeutics plc (Nasdaq: ADAP), ("Adaptimmune" or the "Company"), a clinical stage biopharmaceutical company focused on the use of T-cell therapy to treat cancer, reported that the first patient has been dosed in its expanded Phase I/II trial of its affinity enhanced T-cell receptor (TCR) therapeutic targeting the NY-ESO-1 cancer antigen in synovial sarcoma patients (Press release, Adaptimmune, SEP 1, 2015, View Source [SID:1234507364]).

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Based on encouraging results in the first cohort of 10 patients, presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in April 2015, the trial is being expanded to encompass an additional 20 patients in two further cohorts.

The expansion of Adaptimmune’s trial also triggers two milestone payments from GlaxoSmithKline (GSK). Adaptimmune is collaborating with GSK for the development of its NY-ESO TCR program through a strategic cancer immunotherapy partnership announced in June 2014. Under the terms of the agreement, GSK has an exclusive option to license Adaptimmune’s NY-ESO TCR therapeutic and upon exercise would assume full responsibility for further development and commercialization of the therapeutic.

"We are encouraged by the promising data from the first cohort of patients and pleased to have commenced enrollment into the next two cohorts of this study," commented Dr. Rafael Amado, Adaptimmune’s Chief Medical Officer. "Metastatic synovial sarcoma is largely incurable, with as few as 20 percent of patients surviving for more than two years after diagnosis. In the first cohort of this trial, we saw evidence of antitumor activity resulting from treatment with our NY-ESO TCR therapeutic in a solid tumor setting. These early data provide confidence to expand the trial in these patients who currently lack proven, effective treatment options."

Synovial sarcoma is a cancer of the connective tissue and a type of solid tumor primarily affecting adolescents and young adults. Most metastatic soft tissue sarcomas are currently incurable – 75 to 80 percent of patients do not survive past two to three years – and there are limited treatment options for unresectable and recurrent synovial sarcoma, which is nearly always fatal.

Adaptimmune’s clinical study includes synovial sarcoma patients who have received standard first line therapy containing ifosfamide and/or doxorubicin and who are intolerant or no longer responding to the regimen, and whose tumor expresses a tumor antigen known as NY-ESO-1. The NY-ESO-1 antigen is believed to be present in 60 to 70 percent of synovial sarcoma patients.

The primary objectives of the study are to determine the safety of adoptively transferred autologous T cells expressing an affinity enhanced T cell receptor that recognizes the NY-ESO-1 antigen in HLAA*0201, HLA-A*0205, and/or HLA-A*0206 positive patients with unresectable, metastatic or recurrent synovial sarcoma. Secondary objectives include the determination of efficacy through response rate and duration of response.

All eligible patients will be treated with lymphodepletive chemotherapy followed by administration of Adaptimmune’s NY-ESO TCR therapeutic. In the first cohort, patients whose tumor expressed NY-ESO-1 at high levels received a single course of cyclophosphamide and fludarabine for lymphodepletion prior to administration of Adaptimmune’s NY-ESO TCR therapeutic. Cohort 2 will enroll patients whose tumor expresses lower levels of the NY-ESO-1 antigen and who will receive the same treatment as patients in the first cohort. Cohort 3 will enroll patients whose tumor expresses high levels of the NY-ESO-1 antigen and will study the removal of fludarabine as part of the lymphodepletion regimen. Both cohorts are expected to open concurrently.
For more information on the trial, visit ClinicalTrials.gov at: View Source (Identifier: NCT01343043).

Adaptimmune is currently running trials in multiple cancers across the U.S. targeting the NY-ESO-1 cancer antigen in both solid and hematologic cancers. As of May 30, 2015, 85 patients had been treated with Adaptimmune’s NY-ESO TCR therapeutic: 47 under Adaptimmune’s IND, and 38 under a National Cancer Institute IND. Data from the Company’s Phase I/II study in synovial sarcoma were presented at AACR (Free AACR Whitepaper). As of April 20, 2015, 11 patients in the first cohort had received Adaptimmune’s NY-ESO TCR therapeutic. Of the first 10 patients, six responded, with one complete response. Data from Adaptimmune’s Phase I/II study in 20 patients with advanced multiple myeloma were published in Nature Medicine online on July 20, 2015 and in the print publication on August 6, 2015.

About synovial sarcoma
Soft tissue sarcomas can develop from soft tissues including fat, muscle, nerves, fibrous tissues, blood vessels, or deep skin tissues, and synovial sarcoma, a cancer of the connective tissue around the joints, accounts for approximately 6 to 10 percent of all soft tissue sarcomas. Approximately one third of synovial sarcomas occur in childhood and the peak incidence is in the third decade of life, with 70 percent of sarcomas occurring in patients younger than 40 years old. The majority of patients who develop metastatic soft tissue sarcomas are currently incurable, with 75 to 80 percent of patients not surviving past two to three years. First line therapy typically involves radiotherapy and chemotherapy, as well as surgical resection where possible.