On October 19, 2018 Boehringer Ingelheim reported results from GioTag, a real-world retrospective study which examined the impact of first-line Giotrif/Gilotrif (afatinib) followed by osimertinib, in epidermal growth factor receptor mutation-positive (EGFR M+) non-small cell lung cancer (NSCLC) patients with acquired T790M mutations, the most common mechanism of resistance to first- and second-generation EGFR tyrosine kinase inhibitors (TKIs) (Press release, Boehringer Ingelheim, OCT 19, 2018, View Source [SID1234529984]). The results showed that the sequential strategy was effective in delaying subsequent chemotherapy treatment and were published today in the journal Future Oncology.

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According to the study, the median time on treatment for sequential afatinib and osimertinib was 27.6 months. In this broad, real-world population, the clinical benefit was consistent across all patient subgroups, with particularly encouraging results seen in those with exon 19 deletion (Del19)-positive disease (median time on treatment 30.3 months) and Asian patients (median time on treatment 46.7 months). Additionally, the 2 year and 2.5 year overall survival (OS) rates were 78.9% and 68.8%, respectively.1

Among the patients included in this study, 15.3% had a poor performance status at the start of afatinib treatment (as defined by ECOG performance status ≥2), ordinarily precluding them from clinical trials.1

While osimertinib is an effective first-line treatment,2 there is a lack of approved subsequent TKI treatment options, and many patients progress to chemotherapy following osimertinib failure.1 The results suggest that the sequential strategy of afatinib and osimertinib might offer sustained clinical benefit to a substantial number of patients, prolonging the chemotherapy-free treatment period.1

"With more targeted treatment options becoming available, it is important to understand the impact of multiple lines of targeted therapies on patient outcomes," said Dr. Maximilian J. Hochmair, Medical Oncologist, Department of Respiratory and Critical Care Medicine, Otto Wagner Hospital and coordinating investigator in the trial. "The results of GioTag show that sequential treatment with afatinib and osimertinib is an attractive strategy in patients with EGFR mutation-positive NSCLC, offering a sustained clinical benefit to a substantial number of patients while – importantly – extending the time patients are kept off chemotherapy."

Dr. Victoria Zazulina, Global Head of Solid Tumour Oncology, Medicine at Boehringer Ingelheim, said, "We saw through a recent global survey published at WCLC that many physicians do not feel they have enough information to make informed treatment decisions on how to make the most of the available targeted treatments for patients with EGFR M+ NSCLC; in the absence of randomised data, real-world evidence may help inform treatment decisions. GioTag is the first global study in EGFR M+ NSCLC looking at the sequencing of targeted therapies as it is used in daily clinical practice. These results will provide more insights on the use of EGFR TKIs, looking beyond first-line to maximise overall longer-term impact of targeted therapies in NSCLC."

Results of a recent global survey of HCPs’ attitudes about sequencing treatments for EGFR M+ NSCLC patients are available here. Full results from the GioTag study will be presented at an upcoming medical conference later this year.

On October 19, 2018 AstraZeneca reported its new data on the mechanisms of acquired resistance from the Tagrisso (osimertinib) pivotal Phase III FLAURA trial during an oral late-breaker abstract session at the ESMO (Free ESMO Whitepaper) 2018 Congress (European Society of Medical Oncology) in Munich, Germany (Press release, AstraZeneca, OCT 19, 2018, View Source [SID1234529971]). MET-amplification and the epidermal growth factor receptor (EGFR) C797S mutation were among the most frequent resistance mechanisms observed after treatment with 1st-line Tagrisso in patients with previously-untreated EGFR-mutated (EGFRm) non-small cell lung cancer (NSCLC) who experienced disease progression during the trial period. As expected, there was no evidence of the acquired EGFR T790M mutation in the 1st-line Tagrisso arm.

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Based on those findings, AstraZeneca reported the initiation of a new clinical trial, Osimertinib Resistance CoHorts, Addressing 1L Relapse Drivers (ORCHARD), an open-label, multi-centre, multi-drug Phase II platform trial in patients with advanced NSCLC who have experienced disease progression following 1st-line therapy with Tagrisso.

Klaus Edvardsen, Senior Vice President, Head of Oncology, Global Medicines Development, said: "We are committed to following the science to improve survival for all patients with EGFR-mutation positive NSCLC at every stage of disease. The ORCHARD trial will increase our understanding of resistance mechanisms and explore potential new treatment options to address the next stage of disease after 1st-line Tagrisso."

Dr. Suresh S. Ramalingam, Principal Investigator of the FLAURA trial from Winship Cancer Institute of Emory University, Atlanta, US, said: "The FLAURA trial ushered in a new standard of care with osimertinib as 1st-line therapy for EGFRm NSCLC. Today’s results provide direction for continued research into new treatment options after progression on 1st-line osimertinib therapy by studying MET-amplification and EGFR C797S, among other resistance mechanisms."

Results from the preliminary FLAURA subgroup analysis showed that following treatment with Tagrisso in the 1st-line setting, the most frequent acquired resistance mechanisms detected in patient plasma were MET-amplification (15%) and the EGFR C797S mutation (7%), followed by HER2-amplification and the PIK3CA and RAS mutations (2-7%). For the comparator EGFR-TKI arm, the most frequent acquired resistance mechanism to erlotinib or gefitinib was the EGFR T790M mutation (47%).

Data from the Phase III AURA3 trial, also presented at the congress, were consistent with the FLAURA findings. The most frequent mutations detected in patient plasma after progression with 2nd-line Tagrisso included EGFR C797 mutations (15%; C797S n=10; C797G n=1), MET-amplification (19%), HER2-amplification (5%) and the PIK3CA mutation (5%).

Tagrisso has now received approval in more than 40 countries for the 1st-line treatment of patients with metastatic EGFRm NSCLC, including the US, Japan and in the European Union. Other global health authority reviews and submissions of the 1st-line data are ongoing, including China, with a decision expected in the second half of 2019.

NOTES TO EDITORS
About EGFRm NSCLC

Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-fifth of all cancer deaths, more than breast, prostate and colorectal cancers combined. Lung cancer is broadly split into NSCLC and small cell lung cancer (SCLC), with 80-85% classified as NSCLC. Approximately 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia have EGFRm NSCLC. These patients are particularly sensitive to treatment with EGFR-TKIs which block the cell-signalling pathways that drive the growth of tumour cells. Approximately 25% of patients with EGFRm NSCLC have brain metastases at diagnosis, increasing to approximately 40% within two years of diagnosis. The presence of brain metastases often reduces median survival to less than eight months.

About Tagrisso

Tagrisso (osimertinib) is a third-generation, irreversible EGFR-TKI designed to inhibit both EGFR-sensitising and EGFR T790M-resistance mutations, with clinical activity against central nervous system metastases. Tagrisso 40mg and 80mg once-daily oral tablets have now received approval in more than 40 countries, including the US, Japan and in Europe, for 1st-line EGFRm advanced NSCLC, and more than 80 countries, including the US, Japan, China and in Europe, for 2nd-line use in patients with EGFR T790M mutation-positive advanced NSCLC. Tagrisso is also being developed in the adjuvant setting (ADAURA), in the locally-advanced unresectable setting (LAURA), and in combination with other treatments.

About the FLAURA trial

The FLAURA trial assessed the efficacy and safety of Tagrisso 80mg orally once daily vs. standard-of-care EGFR-TKIs (either erlotinib [150mg orally, once daily] or gefitinib [250mg orally, once daily]) in previously-untreated patients with locally-advanced or metastatic EGFRm NSCLC. The trial was double-blinded and randomised, with 556 patients across 29 countries.

About the ORCHARD trial

ORCHARD is an open-label, multicentre, multi-drug Phase II platform trial in patients with advanced EGFRm NSCLC whose disease has progressed on 1st-line therapy with Tagrisso. The initial trial is expected to have multiple treatment arms which will examine both targeted and non-targeted combination options and plans to recruit 150 patients. As learnings about acquired resistance to Tagrisso from FLAURA accumulate, as well as other trials, additional treatment arms may be added.

About AstraZeneca in Lung Cancer

AstraZeneca has a comprehensive portfolio of approved and potential new medicines in late-stage development for the treatment of lung cancer across all stages of disease and lines of therapy. We aim to address the unmet needs of patients with EGFRm NSCLC with our approved medicines, Iressa and Tagrisso, and with the Phase III ADAURA and LAURA trials.

Our Immuno-Oncology portfolio includes Imfinzi, an anti-PDL1 antibody, which is in development as monotherapy (ADJUVANT, PACIFIC2, MYSTIC and PEARL trials) and in combination with tremelimumab and/or chemotherapy (MYSTIC, NEPTUNE, POSEIDON and CASPIAN trials).

About AstraZeneca in Oncology

AstraZeneca has a deep-rooted heritage in oncology and offers a quickly-growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With at least six new medicines to be launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, we are committed to advance oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy, as illustrated by our investment in Acerta Pharma in haematology.

By harnessing the power of four scientific platforms – Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates – and by championing the development of precision combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.

On October 19, 2018 X4 Pharmaceuticals, a clinical stage biotechnology company developing novel CXCR4 antagonists to improve immune cell trafficking to treat cancer and rare disease, reported results from a pilot study of X4P-001-IO in combination with Opdivo (nivolumab) in patients with clear cell renal cell carcinoma (ccRCC) who are non-responsive to the anti-PD-1 checkpoint inhibitor Opdivo alone (Press release, X4 Pharmaceuticals, OCT 19, 2018, View Source [SID1234529985]). The data will be presented at a Poster Discussion session at CThe data from this study demonstrate that the combination with X4P-001-IO and nivolumab has the potential to augment responses in patients who previously received the anti-PD-1 checkpoint inhibitor nivolumab alone," said Toni K. Choueiri, M.D. Director, Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, and lead investigator of the study. "This pilot study data requires validation in larger studies as we continue to seek treatments to address the larger population of cancer patients who do not adequately respond to checkpoint inhibitors."

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Results were presented from the nine patients with advanced ccRCC enrolled in the pilot study (as of August 1, 2018) who were non-responsive to single agent Opdivo with either stable or progressive disease. Enrolled patients received X4P-001-IO (400 mg, oral, once daily) and continued to receive standard bi-weekly Opdivo therapy. Median duration of treatment with the combination was 3.7 months (range 1-15 months).

Highlights of the data presented at ESMO (Free ESMO Whitepaper) include:

X4P-001-IO in combination with Opdivo was tolerable in ccRCC patients. The most frequent drug related adverse events were diarrhea, nasal congestion, ALT/AST increase, dry eye, fatigue. No grade 4 or 5 adverse events occurred. All Grade 3/serious adverse events were manageable with appropriate intervention.
Combination therapy with X4P-001-IO and Opdivo exhibited anti-tumor activity in some patients with advanced ccRCC who were previously unresponsive to Opdivo monotherapy.
Four patients who had progressed on prior Opdivo monotherapy had a best response of stable disease with the additional X4P-001-IO to Opdivo treatment.
Of the five patients who were stable on prior Opdivo monotherapy, one had a partial response with combination therapy of X4P-001-IO and Opdivo.
Serum biomarker analyses identified significant early changes in cytokines and chemokines, including CXCL9, a chemoattractant ligand for cytotoxic T cell migration.
"These findings add to our clinical experience with X4P-001-IO and our growing understanding of combining CXCR4 antagonists with other agents, such as checkpoint inhibitors," said Ken Gorelick, M.D., Chief Medical Officer of X4 Pharmaceuticals. "X4 continues to explore the important role that CXCR4 antagonism may play in augmenting anti-tumor response in combination with other cancer therapeutic modalities, and therefore, potentially improve outcomes for cancer patients."

About X4P-001-IO in Cancer
X4P-001-IO is an investigational selective, oral, small molecule antagonist of C-X-C receptor type 4 (CXCR4). CXCR4 is a chemokine receptor present in abundance on certain immune cells and cancer cells and it plays a critical role in immune cell trafficking, infiltration and activation in the tumor microenvironment. CXCR4 signaling is disrupted in a broad range of cancers, facilitating tumor growth by allowing cancer cells to evade immune detection and creating a pro-tumor microenvironment. X4P-001-IO has the ability to help restore immunity within the tumor microenvironment and has the potential to enhance the anti-tumor activity of approved and emerging oncology agents, such as checkpoint inhibitors and targeted therapies. X4P-001-IO is being investigated in several clinical studies in solid tumors.

On October 19, 2018 Sensei Biotherapeutics, Inc., a clinical-stage biopharmaceutical company developing precision immuno-oncology therapies, announced today the results of the Phase 1 clinical trial evaluating the safety and immunogenicity of SNS-301 in patients with biochemically recurrent prostate cancer (BRPC) (Press release, Sensei Biotherapeutics, OCT 19, 2018, View Source [SID1234529986]). Patients in the clinical trial were antigen-positive for human aspartate β-hydroxylase (ASPH), a novel tumor-specific embryonic antigen, and selected using Sensei’s proprietary companion diagnostic. SNS-301, a first-in-class immunotherapy candidate targeting ASPH, is the lead clinical candidate in Sensei’s pipeline of innovative cancer immunotherapies created using Sensei’s SPIRIT platform. Results from the Phase 1 study of SNS-301 will be presented at a Poster Discussion session at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress, taking place October 19-23, 2018, in Munich, Germany.

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"The principal outcomes from this study further energize our strategy of pursuing next-generation targets, such as ASPH, combined with visionary bioengineering and precision medicine," said John Celebi, President and Chief Executive Officer of Sensei Biotherapeutics. "Based on these positive results, we plan to initiate a Phase 2 trial for SNS-301 in various hematological malignancies and solid tumors in early 2019. We also plan to accelerate the development of our cell therapy programs targeting ASPH and other novel tumor-specific antigens."

"SNS-301’s strong anti-tumor immune activity was shown through increases in both ASPH-specific CD8+ T-cells and ASPH-specific B-cell responses," said Ildiko Csiki, M.D., Ph.D., Chief Medical Officer of Sensei Biotherapeutics. "Based on these compelling early data showing anti-tumor immune response, coupled with a favorable safety profile, we believe SNS-301 has the potential to benefit patients with ASPH-expressing tumors. In a Phase 2 setting, we plan to focus on head and neck cancer, myelodysplastic syndrome, and additional solid tumor indications."

In the multi-center Phase 1 clinical trial, SNS-301 was administered every 21 days via intradermal injection to BRPC patients using a fixed dose-escalation schema to establish the recommended Phase 2 dose. The clinical trial enrolled 12 patients who were confirmed to express ASPH using Sensei’s proprietary serum-based companion diagnostic test. Patients received between 8 to 23 doses of SNS-301 (with an average of 10 doses per patient) at the three different doses in the study, with the cohort of low-dose patients progressing through to the high dose, and the cohort of mid-dose patients escalating successfully to the high dose.

Data from the Phase 1 trial demonstrated a favorable safety profile, improvements in disease-related parameters, and ASPH-specific immune responses. Highlights of the safety and immunogenicity data presented at ESMO (Free ESMO Whitepaper) include:

At all three dose levels in the Phase 1 trial (2 x 1010, 1 x 1011, 3 x 1011 particles), SNS-301 was well tolerated with a favorable safety profile. No dose-limiting toxicities or grade 4-5 adverse events were observed in the trial.
Eight out of the 12 patients (75%) achieved improvements in PSA doubling time and/or absolute PSA level, leading to decreased PSA velocity and suggesting a disease stabilizing effect of SNS-301.
An average 8-to-10-fold increase in the percentage of ASPH-specific CD8+ T-cells was observed post-treatment, compared to baseline measurements. Peak antigen-specific T-cell levels were observed between 43 and 85 days from initial treatment. All seven patients that were evaluable for immune responses showed increases in ASPH-specific T-cells.
An average 5-to-7-fold increase in the percentage of ASPH-specific B-cell responses was observed post-treatment, compared to baseline measurements. Peak antigen-specific B-cell levels were observed between 64 and 106 days from initial treatment. All 12 patients enrolled had increases in ASPH-specific B-cells.
A strong corresponding increase in anti-ASPH antibody titers across patients correlated with B-cell response and a subsequent reduction in serum-based ASPH was observed.
The recommended Phase 2 dose was identified as the mid-dose (1 x 1011 particles) in the Phase 1 trial based on immunogenicity and PSA results of the three evaluated doses.
Sensei’s planned Phase 2 program will evaluate SNS-301 as monotherapy in hematological malignancies and as combination therapy with checkpoint inhibitors in multiple solid tumors, with clinical trials to be initiated in 2019.

About SNS-301
SNS-301 is a first-in-class cancer immunotherapy targeting human aspartate β-hydroxylase (ASPH), a cell surface enzyme that is normally expressed during embryonic development. Following embryonic development, the protein is no longer expressed in healthy adults. Expression of ASPH is uniquely upregulated in more than 20 different types of cancer and is related to cancer cell growth, cell motility and invasiveness. ASPH signaling occurs through the Notch pathway and expression levels in various tumors are inversely correlated with disease prognosis. SNS-301 is a bio-engineered, inactivated bacteriophage virus expressing a fusion protein of native bacteriophage GPD (Glyceraldehyde-3-phosphate dehydrogenase) protein and a selected domain of ASPH. SNS-301 is designed to overcome immune tolerance and induce robust and durable ASPH-specific humoral and cellular responses. SNS-301 is paired with a companion diagnostic to ensure appropriate patient selection and is delivered easily through an intradermal injection to aid in generating robust immune response.

On October 19, 2018 – Novartis reported presentation of a new analysis of Lutathera (lutetium Lu 177 dotatate*) NETTER-1 data at the 2018 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) congress examining the impact of Lutathera treatment on patients with low, medium or high liver tumor burden (Press release, Novartis, OCT 19, 2018, View Source [SID1234529967]). The data show that Lutathera treatment results in significant improvement in progression free survival (PFS) regardless of the extent of baseline liver tumor burden (LTB), elevated alkaline phosphatase (ALP) liver enzyme or presence of large (>30mm diameter) lesion in patients with progressive midgut neuroendocrine tumors (NETs) compared to octreotide LAR alone[1].

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Lutathera is the first Peptide Receptor Radionuclide Therapy (PRRT) to receive regulatory registration, with approval by the European Commission in September 2017 and by the US Food and Drug Administration (FDA) in January 2018. Lutathera is an Advanced Accelerator Applications product.

"Patients with metastatic midgut NET and a high liver tumor load at diagnosis have a poorer prognosis than patients with few liver metastases[2],[3]," said Jonathan Strosberg, MD, Associate Professor, Section Head, Neuroendocrine Tumor Program at Moffitt Cancer Center, and Principle Investigator of the NETTER-1 study. "These new data provide hope for these patients and reinforce the potential benefit of Lutathera treatment in this population."

Liver tumor burden (LTB) was defined as tumor volume/total liver volume by CT or MRI, and categorized as low (<25%), moderate (25-50%), and high (>50%)[1]. Median PFS (months) in Lutathera arm vs 60 mg octreotide LAR alone was 28.35 vs 11.04 in low (HR=0.218, 95% CI 0.120 to 0.394); Not Reached (NR) vs 8.67 in moderate (HR=0.202, 95% CI 0.077 to 0.525); 19.38 vs 5.52 in high LTB (HR= 0.193, 95% CI 0.079 to 0.474), respectively[1].

Because the numbers of patients and events of deteriorations are small for the moderate and high liver burden groups for quality of life assessments, moderate/high liver burden groups were pooled into one group[1]. Median TTD (months) for global health status (self-assessment of overall health and quality of life) in Lutathera arm vs 60 mg octreotide LAR alone was 28.81 vs 6.11 in low (HR=0.376, 95% CI 0.196 to 0.720); and NR vs 5.98 in moderate/high LTB (HR=0.453, 95% CI 0.178 to 1.152) [1]. Median TTD (months) for physical functioning was 25.20 vs 11.47 in low (HR=0.512, 95% CI 0.264 to 0.994); and NR vs 11.56 in moderate/high LTB (HR=0.526, 95% CI 0.207 to 1.335) [1].

"These results from the NETTER-1 study continue to show that Lutathera delivers strong efficacy in patients with a challenging disease burden," said Samit Hirawat, MD, Head of Novartis Oncology Global Drug Development. "Demonstrating improved PFS and maintenance of QoL in patients with neuroendocrine tumors with poor prognosis due to a high liver tumor burden is a great example of our commitment to reimagining cancer."

Additional sub-analysis evaluated median PFS in patient subgroups with normal or elevated baseline levels of liver enzyme alkaline phosphatase (ALP), and in subgroups with presence or absence of a large (>30 mm diameter) lesion at baseline[1]. Median PFS (months) in Lutathera arm vs 60 mg octreotide LAR alone for the group with normal ALP was 28.35 vs 8.74 (HR=0.204, 95% CI 0.117 to 0.357)[1]. Median PFS (months) in Lutathera arm vs 60 mg octreotide LAR alone for the group with elevated ALP was NR vs 5.78 (HR=0.191, 95% CI 0.090 to 0.405)[1]. Median PFS (months) in Lutathera arm vs 60 mg octreotide LAR alone for the group with a large tumor lesion was 28.35 vs 8.44 (HR=0.266, 95% CI 0.165 to 0.429)[1]. Median PFS (months) in Lutathera arm vs 60 mg octreotide LAR alone for the group without a large tumor lesion was NR vs 8.74 (HR= 0.069, 95% CI 0.021 to 0.233)[1].

The NETTER-1 trial is an international phase III study in patients with progressive, somatostatin receptor-positive midgut neuroendocrine tumors[4]. Patients were randomized to treatment with Lutathera (Lu)(n=117) and best supportive care (30 mg octreotide LAR), or 60 mg octreotide LAR alone (Oct) (n=114). In total, 141 patients had low (71 Lu, 70 Oct), 50 patients had moderate (19 Lu, 31 Oct), and 40 patients had high LTB (27 Lu, 13 Oct).

European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaires, a commonly used metric for analysis of HRQoL in cancer patients, were assessed during the trial to determine the impact of treatment on HRQoL[5]. Patients completed the questionnaires at baseline and every 12 weeks until tumor progression. TTD was defined as the time from randomization to the first QoL deterioration >=10 points (on a 100-point scale) compared to baseline score for the same domain.

About Lutathera
Lutathera (lutetium Lu 177 dotatate*) is a lutetium Lu 177-labeled somatostatin analog peptide. Lutathera belongs to a class of treatments called Peptide Receptor Radionuclide Therapy (PRRT). Lutathera is comprised of a targeting molecule which carries a radioactive component. Lutathera has received orphan drug designation from the FDA and the European Medicines Agency (EMA). In the US, Lutathera is indicated for the treatment of somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults[6]. In Europe, Lutathera is indicated for the treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults[7]. Lutathera can cause serious side effects that may include bone marrow problems, kidney problems, liver problems, hormonal gland problems, fertility problems and problems arising from radiation exposure. Please see Important Safety Information and Full Prescribing Information at: www.lutathera.com.

* USAN: lutetium Lu 177 dotatate / INN: lutetium (177Lu) oxodotreotide