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Daiichi Sankyo Presents New Data for DS-8201 in Multiple HER2-Expressing Solid Tumors at European Society for Medical Oncology (ESMO) 2017 Congress

On September 11, 2017 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported that DS-8201, an investigational HER2-targeting antibody drug conjugate (ADC), demonstrated preliminary antitumor activity in patients with HER2-expressing solid tumors such as colon cancer, non-small cell lung cancer and other tumor types (Press release, Daiichi Sankyo, SEP 11, 2017, View Source [SID1234520480]). These data were presented during a poster session at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2017 Congress in Madrid, Spain.

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Preliminary results from the ongoing DS-8201 phase 1 study showed that DS-8201 demonstrated an overall confirmed response rate of 32 percent and a disease control rate of 82 percent in a subgroup analysis of 22 of 25 evaluable patients with HER2-expressing solid tumors, which included colon cancer (11 patients), non-small cell lung cancer (6 patients), salivary gland cancer (4 patients), Paget’s disease (2 patients), cholangiocarcinoma (1 patient) and esophageal cancer (1 patient). Two of 10 evaluable patients with colon cancer, one out of five evaluable patients with non-small cell lung cancer and three of four evaluable patients with salivary gland cancer achieved partial responses. Two additional patients with colon cancer and non-small cell lung cancer with one post baseline scan showed a partial response yet to be confirmed at subsequent scans. A total of 168 patients have been treated in both the dose escalation (24 patients) and dose expansion (144 patients) parts of the study as of August 1, 2017.

Safety data for 168 patients who received at least one dose of DS-8201 in study parts 1 and 2 and across different cohorts of the study also were reported. The most common adverse events (any grade) seen in all patients to date included nausea (67 percent), decreased appetite (56 percent), vomiting (33 percent), anemia (30 percent) and decreased platelet count (29 percent). Grade 3 adverse events occurring in >10 percent of patients included anemia (13 percent), decreased neutrophil count (14 percent) and decreased white blood cell count (11 percent). Grade 4 adverse events occurred in ≤ 3 percent of patients and included decreased platelet count (3.0 percent), decreased neutrophil count (2.4 percent), decreased white blood cell count (1.8 percent) and anemia (1.2 percent).

"These preliminary results are consistent with other data previously reported in the HER2-positive metastatic breast and gastric cancer cohorts of this study, demonstrating that further study is warranted for DS-8201 across other HER2-expressing solid tumors," said Antoine Yver, MD, MSc, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo. "These data add to the growing body of clinical evidence suggesting that DS-8201 could potentially become an important new treatment option for many different types of solid tumors that overexpress HER2. In addition to initiating our pivotal phase 2 study of DS-8201 in HER2-positive metastatic breast cancer, we are exploring next steps for the development of DS-8201 across multiple HER2-expressing tumor types."

About the DS-8201 Phase 1 Study
The open-label two-part phase 1 dosing study is currently evaluating DS-8201 in patients with advanced/
unresectable or metastatic solid tumors that are refractory or intolerant to standard treatment, or for whom no standard treatment is available. The primary objective of the dose escalation phase of the study was to assess the safety and tolerability of DS-8201 and determine the maximum tolerated dose. In the dose expansion part of the phase 1 study, DS-8201 is given in one of two doses (5.4 mg/kg and 6.4 mg/kg) to patients with HER2-positive advanced or metastatic breast cancer and gastric cancer, HER2 low-expressing breast cancer and other HER2-expressing solid tumors. Patient enrollment in the two breast cancer cohorts is ongoing in the U.S. and Japan. For more information about the study, please visit ClinicalTrials.gov.

About DS-8201
DS-8201 is the lead product in the ADC Franchise of the Daiichi Sankyo Cancer Enterprise. ADCs are a type of targeted cancer medicine that deliver cytotoxic chemotherapy ("payload") to cancer cells via a linker attached to a monoclonal antibody that binds to a specific target expressed on cancer cells. Using Daiichi Sankyo’s proprietary ADC technology, DS-8201 is a smart chemotherapy comprised of a humanized HER2 antibody attached to a novel topoisomerase I inhibitor (DXd) payload by a tetrapeptide linker. It is designed to deliver enhanced cancer cell destruction upon release inside the cell and reduce systemic exposure to the cytotoxic payload (or chemotherapy) compared to the way chemotherapy is commonly delivered.

DS-8201 is currently in phase 2 clinical development for HER2-positive unresectable and/or metastatic breast cancer resistant or refractory to T-DM1 (DESTINY-Breast01), and in phase 1 development for HER2 low-expressing breast cancer, HER2-positive gastric cancer and other HER2-expressing solid tumors.
The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to DS-8201 for the treatment of patients with HER2-positive, locally advanced or metastatic breast cancer who have been treated with trastuzumab and pertuzumab and have disease progression after ado-trastuzumab emtansine (T-DM1), and Fast Track designation for the treatment of HER2-positive unresectable and/or metastatic breast cancer in patients who have progressed after prior treatment with HER2-targeted therapies including T-DM1. DS-8201 is an investigational agent that has not been approved for any indication in any country. Safety and efficacy have not been established, and there is no guarantee DS-8201 will become commercially available.

Advaxis Reports Business Update and Third Quarter 2017 Results

On September 11, 2017 Advaxis, Inc. (NASDAQ:ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, reported a business update and announced its financial results for the third quarter (Q3) ended July 31, 2017 (Press release, Advaxis, SEP 11, 2017, View Source [SID1234520477]).

"The board of directors selected Anthony Lombardo as interim chief executive officer in July, given his 30 years of leadership experience in the life sciences industry, including previous CEO and executive management positions in both public and private companies," said Dr. David Sidransky, chairman of the board at Advaxis. "We’re confident in his abilities and the value he’s already helping to deliver, and he will remain in this role for the foreseeable future. Over the past two months, Lombardo has been leading an effort to conduct a review of the current Advaxis business portfolio and our future strategic direction. We have a strong scientific and clinical asset base on which to build value, and the board and the management team are aligned on the path forward to commercialization. To further strengthen the management team, our top priority is conducting a search for a chief medical officer, to ensure the effective execution of our refined clinical strategy. The board and the management team are aligned on Advaxis’ path forward."

A Four Franchise Approach to Increasing Shareholder Value

This path forward is anchored in the company’s Lm Technology, a proven platform unique in its ability to safely and effectively target various cancers in multiple ways. As the field of immunotherapy continues to evolve, the flexibility of the Lm platform has allowed Advaxis to continue to adapt and introduce highly innovative programs.

"To fully leverage the technology’s potential and enhance the lives of more cancer patients, while also optimizing shareholder value, we’re reprioritizing programs for continued internal clinical development and implementing alternative strategies for others," said Anthony Lombardo, interim chief executive officer at Advaxis.

Advaxis’ sharpened growth strategy centers on four clear, distinct franchises that will drive significant value creation: HPV-associated cancers, prostate cancer, neoantigen therapy and hotspot mutation therapy.

1. Franchise One: HPV- Associated Cancers

Continue our commitment to commercializing axalimogene filolisbac:
Completion of the MAA submission for conditional approval in Europe is on track for year end.
Enrollment continues in eight countries for AIM2CERV to evaluate axalimogene filolisbac as an adjuvant therapy in patients with high-risk locally advanced cervical cancer.
Collaboration with AstraZeneca on the Phase 2 combination trial with durvalumab in cervical and head and neck cancers is ongoing and continues to enroll.
The combination trial with ADXS-DUAL and BMS’s nivolumab for the treatment of women with persistent, recurrent or metastatic cervical cancer will be initiated in 1H 2018. This program will provide a second registrational opportunity in cervical cancer.
Given the promising early data in head and neck and anal cancers, Advaxis is actively pursuing opportunities to continue development through investigator-sponsored trials (ISTs) or other third-party approaches.
2. Franchise Two: Prostate Cancer

Preliminary data presented at the 3rd International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) suggests that ADXS-PSA shows monotherapy activity in prostate cancer that is associated with a distinct immunologic and gene expression pattern. The ongoing trial, ADXS-PSA: Phase 1/2 Study (Keynote-046), evaluates ADXS-PSA as monotherapy and in combination with Merck’s pembrolizumab. The clinical benefit in prostate cancer could be a significant value creator to expand the Lm platform into the prostate cancer market.
In addition, the company is actively developing an additional product for prostate cancer, currently in preclinical testing, which could complement ADXS-PSA.
3. Franchise Three: Personalized Therapies Targeting Neoantigens

ADXS-NEO, in partnership with Amgen Inc., has the potential to be a major step forward in personalized medicine. First patient dosed is expected in 1H 2018.
The initial tumor types for ADXS-NEO are metastatic microsatellite stable colon, head and neck, and non-small cell lung cancers.
4. Franchise Four: Targeting Shared Hotpot Mutations and Tumor Associated Antigens

Advancement of the proprietary ADXS-HOT preclinical program will expand Lm Technology into multiple products targeting several of the most common cancers.
Advaxis expects to file INDs for the first HOT products in 2018.
As part of its portfolio refinement, the company has determined it will not pursue further clinical study of ADXS-HER2 at this time, but remains open to ISTs or licensing opportunities.

"We believe that focusing on these four franchises gives us the greatest opportunity to increase shareholder value and have a significant impact on patients and their families," said Lombardo. "Our excitement about the clinical potential of our Lm Technology is balanced by focus and fiscal discipline."

Financial Highlights for Q3

"The company had a productive third quarter while advancing the development of its core assets," said Sara Bonstein, chief financial officer at Advaxis. "There was increased spend in Q3 due to higher costs to support the regulatory filing of axalimogene filolisbac in Europe, and several one-time costs, which are not anticipated to recur. Our Q4 activities will focus on the execution of our core programs, and the disciplined identification and analysis of additional opportunities to leverage our Lm Technology platform."

Cash, cash equivalents and investments totaled $89.4 million, compared to $115.3 million as of April 30, 2017.
$34.2 million in disbursements include several one-time cash disbursements, among them technical operations costs associated with the European filing of axalimogene filolisbac (which is anticipated to be completed by the end of 2017) and increased clinical trial costs, together totaling approximately $7 million. Cash disbursements are anticipated to normalize in the fourth quarter.
Cash receivables totaled $8.2 million, primarily from partner reimbursements, specifically $4.5 million from Amgen in support of the ADXS-NEO program and $3 million from Stendhal in support of the AIM2CERV program.
Net loss was $70.1 million ($1.74 per share), compared to a net loss of $51.8 million ($1.52 per share) for the same period in 2016, largely due to increased research and development (R&D) expenses.
R&D expenses were $47.8 million, compared to $32.0 million in Q3 2016, related to an increase in clinical trial expense and technical operation support, primarily related to our HPV-franchise.
General and administrative expenses were $33.2 million, compared to $20.4 million in Q3 2016; the difference is primarily attributed to stock and cash compensation expense for past employees, of which approximately $9.5 million was a non-cash expense.
41 million common shares outstanding and 49.5 million shares outstanding on a fully diluted basis as of July 31, 2017.
"We continue to focus on building shareholder value and are committed to bringing clinically beneficial solutions to our patients and their families," said Lombardo.

To learn more about Advaxis and its immunotherapy clinical programs, visit www.advaxis.com.

Kancera announces start of Phase 1 Multiple Ascending Dose Trial of KAND567

On September 11, 2017 Kancera reported that it has launched the second part of the ongoing clinical Phase I study of KAND567 (Press release, Kancera, SEP 11, 2017, View Source [SID1234520475]). During this part of the study, KAND567 is administered to groups of healthy subjects in increasing doses, twice a day for seven days. The study is scheduled for completion in the fourth quarter of 2017.

KAND567 works by blocking the Fractalkine system and has been demonstrated in preclinical disease models to effectively combat relapses in autoimmune disease as well as nerve inflammation and pain associated with chemotherapy against cancer.

In the clinical study KAND567 is administered orally to a total of 80 subjects, first in single doses and then in multiple doses. The purpose of the study is to evaluate KAND567 in healthy volunteers in terms of safety, tolerance and pharmacokinetics (drug absorption, exposure and excretion) as well as food interaction (how food affects the absorption of the drug in the body).

The study will be carried out at the QPS facility in Groningen. QPS is an internationally established contract research company that performs clinical studies, develops drug preparations and conducts laboratory analyses according to GLP and GCP quality standards (Good Laboratory Practice and Good Clinical Practice).

About the Fractalkine project
KAND567 is an orally available small molecule that blocks CX3CR1, the Fractalkine receptor. Fractalkine is an immune-modulating factor, a so-called chemokine, which transmits signals via the CX3CR1 receptor, thereby controlling the function of immune cells and cancer cells. The levels of Fractalkine molecules and CX3CR1 receptors have been shown to be elevated in several inflammatory diseases, in cancer and in chronic pain conditions.

Kancera’s drug candidate KAND567 is the most advanced drug candidate against CX3CR1 and has been shown to be effective against inflammation and pain in multiple preclinical disease models.

In the healthy individual, Fractalkine and its receptor, CX3CR1, regulate migration of immune cells from the blood capillary wall into areas where the immune system is needed. Cancer cells use the same system (CX3CR1 and Fractalkine) to invade healthy organs and form metastases. In addition, the presence of Fractalkine has been associated with a lack of effect of immuno-oncological drugs. Therefore, Kancera evaluates how well KAND567 can stop tumor growth.

Animal studies show that Fractalkine’s receptor is not essential for survival and that important immune functions remain intact despite the lack of receptor. The basis for successful development of KAND567 lies in effectively addressing local inflammation while maintaining a healthy immune system.

In clinical trials, blocking of the Fractalkine system has been shown to have the desired effect against auto-immune diseases such as Crohn’s disease and rheumatoid arthritis in refractory patients. These studies have been conducted by the pharmaceutical company Eisai using a monoclonal antibody. The results of these studies indicate that the probability increases for the Kancera AB drug candidate KAND567 to achieve clinical and commercial success as the first small-molecule drug that works through the Fractalkine system to combat many common diseases.

ASTRAZENECA PRESENTS SUPERIOR PROGRESSION-FREE SURVIVAL FOR IMFINZI IN THE PACIFIC TRIAL OF PATIENTS WITH LOCALLY-ADVANCED UNRESECTABLE LUNG CANCER AT ESMO 2017 CONGRESS

On September 11, 2017AstraZeneca and MedImmune, its global biologics research and development arm, reported that they have presented the full PFS data from a planned interim analysis of the Phase III PACIFIC trial (Press release, AstraZeneca, SEP 11, 2017, View Source [SID1234520474]). Results show that Imfinzi (durvalumab) demonstrated a statistically-significant and clinically-meaningful improvement in PFS compared to current standard of care with active surveillance in patients with locally-advanced (Stage III), unresectable non-small cell lung cancer (NSCLC) who had not progressed following standard platinum-based chemotherapy concurrent with radiation therapy (CRT).

Results of the Phase III PACIFIC trial, included at the Presidential Symposium I of the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) 2017 Congress in Madrid, Spain, show an improvement in PFS of more than 11 months in patients treated with Imfinzi compared to placebo (full details in table below). The PFS improvement with Imfinzi was observed across all pre-specified subgroups, including PD-L1 expression status. Patients receiving Imfinzi also had a lower incidence of metastases than those receiving placebo. The PACIFIC trial continues to evaluate overall survival (OS), the other primary endpoint. Detailed results of the PACIFIC trial are published online in the New England Journal of Medicine.

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: "The Phase III PACIFIC results are incredibly encouraging for a patient population that until now has been without treatment options. As the first Immuno-Oncology medicine to achieve improvement in progression-free survival in this setting, Imfinzi is showing clear potential to become a new standard of care for patients with locally-advanced, unresectable NSCLC who have not progressed following chemoradiation."

Dr. Luis Paz-Ares, Principal Investigator of the PACIFIC trial, from the Hospital Universitario Doce de Octubre, Madrid, Spain, said: "For patients with locally-advanced unresectable NSCLC who have completed chemoradiation therapy, Imfinzi represents a potential new treatment option in the context of clear unmet clinical need. Durvalumab overtly prolongs the period in which the disease is controlled with reasonable side effects. In addition, it offers hope to increase the cure rate in this setting, but more mature follow-up is needed to assess its impact on survival."

Summary of key efficacy results:
Endpoint
Medicine
Value
Hazard ratio (HR)/Confidence interval (CI)
PFS*(first primary endpoint)

Imfinzi
16.8 months (median)
HR 0.5295% CI, 0.42-0.65, p<0.0001
Placebo
5.6 months(median)
Duration of response (DoR)
Imfinzi
Not reached
N/A
Placebo
13.8 months
Objective Response Rate (ORR) as measured from baseline scan post-CRT completion
Imfinzi
28.4%
95% CI, 24.28-32.89, p<0.001
Placebo
16.0%
95% CI, 11.31-21.59, p<0.001
* Time from randomisation to the first documented tumour progression, or death in the absence of progression. Randomisation in the PACIFIC trial occurred up to 6 weeks after completion of concurrent chemoradiation therapy (cCRT) and cCRT typically lasted at least 6 weeks. If the PFS had been measured prior to cCRT, it would add approximately 3 months or longer to the PFS value for each arm.

Among patients receiving Imfinzi, the most frequent treatment-related adverse events (AEs) vs. placebo were cough (35.4% vs 25.2%), pneumonitis/radiation pneumonitis (33.9% vs 24.8%), fatigue (23.8% vs 20.5%), dyspnoea (22.3% vs 23.9%) and diarrhoea (18.3% vs 18.8%). 29.9% of patients experienced a grade 3 or 4 AE vs. 26.1% for placebo, and 15.4% of patients discontinued treatment due to AEs compared to 9.8% of patients on placebo.

On 31 July 2017, Imfinzi received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA) as a potential treatment for patients with locally advanced, unresectable NSCLC whose disease has not progressed following platinum-based chemoradiation therapy.

AstraZeneca is in discussions with global health authorities regarding regulatory submissions for Imfinzi based on the PACIFIC data. A status of regulatory submissions is usually provided with the Company’s quarterly results announcement.

Imfinzi received accelerated approval from the US Food and Drug Administration for previously treated patients with advanced bladder cancer and is under review in Canada and Australia for similar use.

About Locally Advanced (Stage III) NSCLC
Stage III lung cancer is divided into two stages (IIIA and IIIB), which are defined by how much the cancer has spread locally and the possibility of surgery. This differentiates it from Stage IV disease, when the cancer has spread (metastasised) to other organs.

Stage III lung cancer represents approximately one-third of NSCLC incidence and was estimated to affect around 105,000 patients in the G7 countries in 2016. More than half of these patients have tumours that are unresectable. The current standard of care is chemotherapy and radiation followed by active surveillance to monitor for progression. The prognosis remains poor and long-term survival rates are low.

About PACIFIC
The PACIFIC trial is a randomised, double-blinded, placebo-controlled, multi-centre trial of Imfinzi as sequential treatment in unselected patients with locally-advanced, unresectable (Stage III) NSCLC who have not progressed following platinum-based chemotherapy concurrent with radiation therapy.

The trial is being conducted in 235 centres across 26 countries involving approximately 700 patients. The primary endpoints of the trial are progression-free survival (PFS) and overall survival (OS), and secondary endpoints include landmark PFS and OS, objective response rate (ORR) and duration of response.

About Imfinzi
Imfinzi (durvalumab), a human monoclonal antibody directed against PD-L1, blocks PD-L1 interaction with PD-1 and CD80 on T cells, countering the tumour’s immune-evading tactics and inducing an immune response.

Imfinzi continues to be studied in multiple monotherapy trials and combination trials with tremelimumab and other potential new medicines in Immuno-Oncology. Imfinzi is being assessed in Phase III trials as a monotherapy in various stages of NSCLC, in small-cell lung cancer (SCLC), in metastatic urothelial cancer (mUC) and in head and neck squamous cell carcinoma (HNSCC). The combination of Imfinzi and tremelimumab is being assessed in Phase III trials in NSCLC, SCLC, mUC and HNSCC and in Phase I/II trials in hepatocellular carcinoma and haematological malignancies.

About AstraZeneca in Lung Cancer
AstraZeneca is committed to developing therapies to help every patient with lung cancer. We have two approved therapies and a growing pipeline that targets genetic changes in tumour cells and boosts the power of the immune response against cancer. Our unrelenting pursuit of science aims to deliver more breakthrough therapies with the goal of extending and improving the lives of patients across all stages of disease and lines of therapy.

About AstraZeneca’s Approach to Immuno-Oncology (IO)
Immuno-Oncology (IO) is a therapeutic approach designed to stimulate the body’s immune system to attack tumours. At AstraZeneca and MedImmune, our biologics research and development arm, our IO portfolio is anchored by immunotherapies that have been designed to overcome anti-tumour immune suppression. We believe that IO-based therapies will offer the potential for life-changing cancer treatments for the vast majority of patients.

We are pursuing a comprehensive clinical trial programme that includes Imfinzi (anti-PD-L1) monotherapy and in combination with tremelimumab (anti-CTLA-4) in multiple tumour types, stages of disease, and lines of therapy, using the PD-L1 biomarker as a decision-making tool to define the best potential treatment path for a patient. In addition, the ability to combine our IO portfolio with small, targeted molecules from across our oncology pipeline, and with those of our research partners, may provide new treatment options across a broad range of tumours.

Transgene Receives FDA IND Approval to Begin a Clinical Trial with TG4010 + Nivolumab + Chemotherapy in the First-Line Treatment of Lung Cancer (NSCLC)

On September 11, 2017 Transgene (Paris:TNG), a biotech company that designs and develops viral-based immunotherapies, reported that the US Food and Drug Administration (FDA) has granted Transgene Investigational New Drug (IND) clearance to proceed with a Phase 2 clinical trial of TG4010 in combination with Opdivo (nivolumab) and chemotherapy as a first-line treatment for advanced non-squamous non-small cell lung cancer (NSCLC) in the USA (Press release, Transgene, SEP 11, 2017, View Source [SID1234520473]).

The Phase 2 clinical trial will explore the potential of combining Transgene’s TG4010, an investigational therapeutic vaccine, in association with Bristol-Myers Squibb’s immune checkpoint inhibitor, nivolumab, which acts by overcoming immune suppression. Both therapies will be combined with standard chemotherapy in first-line NSCLC patients, whose tumors express low and undetectable levels of PD-L1.

Transgene is the sponsor of this international trial. Transgene has signed a clinical collaboration agreement with Bristol-Myers Squibb, which will provide nivolumab for the study (see press release dated April 25, 2017).

The Phase 2 trial will evaluate objective tumor responses and disease control. The study will also assess the safety and tolerability of the regimen together with other efficacy parameters. This multi-center single-arm trial will enroll patients both in the USA and Europe.

The first patient is expected to be included into this Phase 2 study at the end of 2017.

"We are very pleased that the FDA approval for the trial combining TG4010, nivolumab and chemotherapy as a first-line treatment of non-squamous NSCLC has been granted to Transgene" said Maud Brandely, Chief Medical Officer of Transgene. "Advanced lung cancer remains a high medical need, in particular for patients whose tumors express low or undetectable levels of PD-L1. We are looking forward to advancing this clinical trial and evaluate the potential of this triple combination regimen as a better treatment option for these patients."

About TG4010
TG4010 is an immunotherapy that has been designed to express the coding sequences of the MUC1 tumor-associated antigen and the cytokine, Interleukin-2 (IL2). It is based on a modified vaccinia virus (MVA), and has been shown to induce an immune response against MUC1 expressing tumors, such as non-small cell lung cancer (NSCLC).
The combination of TG4010 immunotherapy and chemotherapy has demonstrated significant efficacy in terms of progression-free survival and overall survival in patients with advanced stage NSCLC. The results from the Phase 2b TIME trial with TG4010 in conjunction with chemotherapy in NSCLC have been published in the peer-reviewed medical journal, The Lancet Oncology in December 2015.

About Non-Small Cell Lung Cancer
Lung cancer is one of the most common malignancies worldwide with an estimated 1.8 million new cases annually. It is also a leading cause of cancer-related deaths, accounting for an estimated nearly 1.6 million deaths in 2012 (Source: GLOBOCAN 2012). Advanced lung cancer remains one of the cancer types with the worst prognosis (five-year survival rate for advanced NSCLC of less than 5%), underlining the still unmet need in this disease.