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Loxo Oncology Announces Details of LOXO-292 Clinical Data Presentations at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting

On May 16, 2018 Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, reported that study investigators will present interim data from the ongoing Phase 1 clinical trial for LOXO-292, the company’s highly selective RET inhibitor, in oral and poster presentations at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting held June 1 – 5, 2018 in Chicago, Illinois (Press release, Loxo Oncology, MAY 16, 2018, View Source [SID1234526707]).

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The oral presentation is entitled "A Phase 1 Study of LOXO-292, A Potent and Highly Selective RET Inhibitor, in Patients with RET-Altered Cancers." The submitted abstract utilized a January 2018 data cut-off date. The presentation at the ASCO (Free ASCO Whitepaper) Annual Meeting will utilize an April 2018 data cut-off date. The efficacy data have improved between the January and April data cut-off dates. The abstract has been selected for the "Best of ASCO (Free ASCO Whitepaper)" program.

Additionally, an analysis of patients’ plasma cell free DNA during treatment with LOXO-292 will be presented in a separate poster presentation, entitled "Detection and Clearance of RET Variants in Plasma Cell Free DNA (cfDNA) from Patients (pts) Treated with LOXO-292."

The schedule for the oral and poster presentations are as follows:

Title: A Phase 1 Study of LOXO-292, A Potent and Highly Selective RET Inhibitor, in Patients with RET-Altered Cancers
Presentation Date & Time: Saturday, June 2, 2018, 8:00 – 9:30 a.m. CT
Abstract Number: 102
Session Title: Tumor Genomics: Finding the Target, Hitting the Target
Location: Hall D1
Presenter: Alexander E. Drilon, M.D.

Title: Detection and Clearance of RET Variants in Plasma Cell Free DNA (cfDNA) from Patients (pts) Treated with LOXO-292
Presentation Date & Time: Sunday, June 3, 2018, 8:00 – 11:30 a.m. CT
Abstract Number: 9048
Poster Board Number: 371
Session Title: Lung Cancer—Non-Small Cell Metastatic
Location: Hall A

Conference Call and Webcast Information
Loxo Oncology will be hosting a conference call and live webcast with slides and Q&A on Saturday, June 2, 2018 at 4:00 p.m. CT to discuss the LOXO-292 data after they are presented at ASCO (Free ASCO Whitepaper). To participate in the conference call, please dial (877) 930-8065 (domestic) or (253) 336-8041 (international) and refer to conference ID 3597058. A live webcast of the presentation will be available at View Source A replay of the webcast will be available shortly after the conclusion of the call and archived on the company’s website for 30 days following the call.

About LOXO-292
LOXO-292 is a potent, oral and selective investigational new drug in clinical development for the treatment of patients with cancers that harbor abnormalities in the rearranged during transfection (RET) kinase. RET fusions have been identified in approximately 2% of non-small cell lung cancer, 10-20% of papillary thyroid cancer, and a subset of colon and other cancers. RET point mutations account for approximately 60% of medullary thyroid cancer. Both RET fusion and select RET mutated cancers are primarily dependent on this single activated kinase for their proliferation and survival. This dependency, often referred to as "oncogene addiction," renders such tumors highly susceptible to small molecule inhibitors targeting RET. LOXO-292 was designed to inhibit native RET signaling as well as anticipated acquired resistance mechanisms that could otherwise limit the activity of this therapeutic approach. LOXO-292 is currently being studied in a Phase 1 trial. Interested patients and physicians can contact the Loxo Oncology Physician and Patient RET Clinical Trial Hotline at 1-855-RET-4-292 or email [email protected].

Karyopharm to Present Selinexor Phase 2 SEAL Data at the American Society of Clinical Oncology 2018 Annual Meeting

On May 16, 2018 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, reported that four posters will be presented at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2018 Annual Meeting taking place June 1-5, 2018 in Chicago (Press release, Karyopharm, MAY 16, 2018, View Source [SID1234526706]). Among the poster presentations will be results from the Company’s Phase 2 SEAL study evaluating selinexor, its lead, oral SINE compound, in patients with advanced de-differentiated liposarcoma. The remaining posters will highlight clinical and preclinical data from ongoing investigator-sponsored trials evaluating selinexor in combination with other anti-cancer agents.

"Dedifferentiated liposarcoma is a rare and aggressive form of the disease that is resistant to both standard chemotherapy and radiation, and most patients who progress following surgery ultimately succumb to this difficult to treat cancer," said Sharon Shacham, PhD, MBA, President and Chief Scientific Officer of Karyopharm. "We previously reported positive top-line data from the Phase 2 SEAL study in September 2017, including oral selinexor’s demonstration of superiority over placebo for the study’s primary endpoint of progression-free survival (PFS), with a hazard ratio of 0.60, representing a 40% reduction in the risk of progression or death. The Phase 3 portion of the SEAL study is currently ongoing with top-line data expected by the end of 2019. We look forward to presenting the more detailed results from the Phase 2 portion of the SEAL study at ASCO (Free ASCO Whitepaper) this year."

Details for the ASCO (Free ASCO Whitepaper) 2018 selinexor presentations are as follows:

Company-sponsored Trials

Title: Phase 2 results of selinexor in advanced de-differentiated (DDLS) liposarcoma (SEAL) study: A phase 2/3, randomized, double blind, placebo controlled cross-over study
Lead author:Mrinal Gounder, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College
Poster Board #: 257
Abstract #: 11512
Poster Discussion Session: Sarcoma
Date and Time:Saturday, June 2, 2018; 8:00 AM – 11:30 AM CT; Discussion from 3:00 PM – 4:15PM
Location: Hall A

Investigator-sponsored Trials

Title: Phase 1 study of selinexor plus mitoxantrone, etoposide, and cytarabine in acute myeloid leukemia
Lead author:Bhavana Bhatnagar, Ohio State University Comprehensive Cancer Center
Poster Board #: 108
Abstract: 7048
Poster Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Date and Time:Monday, June 4, 2018; 8:00 AM – 11:30 AM CT
Location: Hall A

Title: Phase 1b study of selinexor, a first in class selective inhibitor of nuclear export (SINE) compound, in combination with doxorubicin in patients (pts) with locally advanced or metastatic soft tissue sarcoma (STS)
Lead author: Eoghan Ruadh Malone, Princess Margaret Cancer Centre
Poster Board #: 307
Abstract: 11562
Poster Session: Sarcoma
Date and Time:Saturday, June 2, 2018; 8:00 AM – 11:30 AM CT
Location: Hall A

Title: Profiling the immune checkpoint pathway in acute myeloid leukemia
Lead author:Paola Dama, University of Chicago
Poster Board #: 75
Abstract: 7015
Poster Discussion Session: Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and Allotransplant
Date and Time:Monday, June 4, 2018; 8:00 AM – 11:30 AM CT; Discussion from 11:30 AM – 12:45 PM CT
Location: Hall A

About Selinexor

Selinexor (KPT-330) is a first-in-class, oral Selective Inhibitor of Nuclear Export / SINE compound. Selinexor functions by binding with and inhibiting the nuclear export protein XPO1 (also called CRM1), leading to the accumulation of tumor suppressor proteins in the cell nucleus. This reinitiates and amplifies their tumor suppressor function and is believed to lead to the selective induction of apoptosis in cancer cells, while largely sparing normal cells. To date, over 2,400 patients have been treated with selinexor. In April 2018, Karyopharm reported positive top-line data from the Phase 2b STORM study evaluating selinexor in combination with low-dose dexamethasone in patients with penta-refractory multiple myeloma. Selinexor has been granted Orphan Drug Designation in multiple myeloma and Fast Track designation for the patient population evaluated in the STORM study. Karyopharm plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) during the second half of 2018, with a request for accelerated approval for oral selinexor as a new treatment for patients with penta-refractory multiple myeloma. The Company also plans to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in early 2019 with a request for conditional approval. Selinexor is also being evaluated in several other mid- and later-phase clinical trials across multiple cancer indications, including in multiple myeloma in a pivotal, randomized Phase 3 study in combination with Velcade (bortezomib) and low-dose dexamethasone (BOSTON) and as a potential backbone therapy in combination with approved therapies (STOMP), and in diffuse large B-cell lymphoma (SADAL), liposarcoma (SEAL), and an investigator-sponsored study in endometrial cancer (SIENDO), among others. Additional Phase 1, Phase 2 and Phase 3 studies are ongoing or currently planned, including multiple studies in combination with one or more approved therapies in a variety of tumor types to further inform Karyopharm’s clinical development priorities for selinexor. Additional clinical trial information for selinexor is available at www.clinicaltrials.gov.

Jounce Therapeutics to Present Data from Ongoing ICONIC Trial of JTX-2011 at the 2018 American Society of Clinical Oncology Annual Meeting

On May 16, 2018 Jounce Therapeutics, Inc. (NASDAQ:JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported that data from its ongoing Phase 1/2 ICONIC trial, an adaptive design, open label trial evaluating JTX-2011 monotherapy and in combination with nivolumab, will be the subject of an oral presentation at the upcoming 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, IL on June 1-5, 2018 (Press release, Jounce Therapeutics, MAY 16, 2018, View Source;p=RssLanding&cat=news&id=2349498 [SID1234526705]). The abstract published today online reflects data as of January 27, 2018 and updated results will be presented on June 2, 2018.

Jounce has met its target enrollment for the Phase 1/2 ICONIC trial in its combination cohorts across four solid tumor types: gastric cancer, triple negative breast cancer (TNBC), head and neck squamous cell cancer (HNSCC) and non-small cell lung cancer (NSCLC), with most patients completing at least one efficacy assessment. Updated results, including preliminary efficacy data on all evaluable patients in the trial, will be presented at ASCO (Free ASCO Whitepaper).

"The preliminary data from patients across multiple solid tumor types enrolled in the ICONIC trial show that JTX-2011 is well-tolerated alone and in combination with nivolumab and has demonstrated evidence of biologic activity and tumor reductions in heavily pre-treated patients who have failed all available therapies. In addition, a potential surrogate biomarker of response has been identified that may help to guide JTX-2011 development," said Elizabeth Trehu, M.D., chief medical officer of Jounce Therapeutics. "We look forward to continuing clinical development of JTX-2011."

Details of the Oral Presentation

Title: ICONIC: Biologic and clinical activity of first in class ICOS agonist antibody JTX-2011 +/- nivolumab (nivo) in patients (pts) with advanced cancers

Session: Developmental Therapeutics – Immunotherapy
Date and Time: Saturday, June 2, 2018, 3:00 – 3:12 p.m. CT (4:00 – 4:12 p.m. ET)
Abstract Number: 3000
Location: Hall B1
Presenter: Timothy A. Yap, MBBS, PhD, MRCP, BS, The University of Texas MD Anderson Cancer Center

Full session details and data presentation at the 2018 ASCO (Free ASCO Whitepaper) Annual Meeting can be found at www.asco.org.

ASCO Abstract and Presentation
The ASCO (Free ASCO Whitepaper) abstract includes preliminary efficacy data from Phase 1 and 2 patients with gastric cancer and TNBC; pharmacodynamic data from Phase 1 that supported Phase 2 dose selection; and safety data from all Phase 2 subjects.

At the presentation, Jounce will provide longer-term follow-up from patients included in the abstract as well as preliminary efficacy data on all evaluable patients in the trial as of an April 4, 2018 cut-off date. This includes data from tumor specific cohorts in gastric cancer, TNBC, HNSCC, NSCLC and other solid tumors. Phase 1 and 2 monotherapy and combination safety data in all patients will be presented, as well as biomarker information on ICOS expression including the emergence of an ICOS high peripheral blood T cell population. Initial Phase 1 safety, PK and PD were previously reported at the 2017 ASCO (Free ASCO Whitepaper) Annual Meeting.

Jounce Therapeutics to Host Event and Webcast
Jounce Therapeutics will host an investor and analyst event beginning at 6:30 p.m. CT (7:30 pm ET) and live webcast beginning at 7:00 p.m. CT (8:00 p.m. ET), both on Monday, June 4, 2018. To access the live webcast, please visit the "Events & Presentations" page in the Investors and Media section of the company’s website at www.jouncetx.com. The webcast will be archived and made available for replay on the company’s website approximately two hours after the call and will be available for 30 days thereafter.

About JTX-2011
Jounce’s lead product candidate, JTX-2011, is a monoclonal antibody that binds to and activates ICOS, a protein on the surface of certain T cells. Preclinical data support that JTX-2011 may have a dual mechanism of action that stimulates anti-tumor T effector cells, and also reduces the immunosuppressive T regulatory cells in the tumor microenvironment. The company is developing JTX-2011 to treat solid tumors as a single agent and in combination with other therapies.

ImmunoGen Announces Positive Findings from the FORWARD II Study of Mirvetuximab Soravtansine Combination Regimens with Avastin® and Carboplatin in Ovarian Cancer

On May 16, 2018 ImmunoGen, Inc., (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer reported positive data from the FORWARD II trial evaluating mirvetuximab soravtansine in multiple combination cohorts in patients with folate receptor alpha (FRα)-positive ovarian cancer (Press release, ImmunoGen, MAY 16, 2018, View Source [SID1234526704]). Results from the cohort assessing mirvetuximab in combination with Avastin (bevacizumab) in patients with platinum-resistant disease will be presented at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which is being held June 1-5 in Chicago, IL. In addition, ImmunoGen reported updated data from the dose-escalation cohort evaluating mirvetuximab in combination with carboplatin in patients with recurrent platinum-sensitive ovarian cancer.

"Building upon the encouraging data generated with mirvetuximab monotherapy, we have looked to expand our addressable patient population through combination regimens with both currently approved and experimental agents in ovarian cancer. In dose escalation, we have demonstrated that full dose mirvetuximab can be combined safely with full doses of Avastin, carboplatin, or Keytruda, with encouraging preliminary clinical activity," said Anna Berkenblit, MD, Vice President and Chief Medical Officer of ImmunoGen. "The promising new data reported in the FORWARD II Avastin and carboplatin arms support the potential of mirvetuximab combinations in earlier lines of therapy. Together, these results have informed the triplet combination study with mirvetuximab plus carboplatin and Avastin, which we initiated last quarter."

Berkenblit continued, "In addition, we plan to present initial data from the Keytruda expansion cohort later this year, building upon the dose escalation data recently presented at SGO. The totality of these data from FORWARD II will guide the next stages of development of mirvetuximab and support a path to registration for combination regimens."

DATA FROM FORWARD II EXPANSION COHORT WITH AVASTIN
Mirvetuximab soravtansine in combination with Avastin in patients with platinum-resistant ovarian cancer has demonstrated anti-tumor activity with durable responses and a favorable tolerability profile, particularly among the subset of patients who have received up to three prior lines of therapy and have medium or high levels of FRα expression. This is the population being studied in the FORWARD I Phase 3 registration trial.

Key findings in 59 patients with platinum-resistant ovarian cancer include:

In the subset of 23 patients evaluable for response with medium or high FRα expression levels who have received up to three prior lines of therapy, the confirmed overall response rate (ORR) was 48 percent (95% CI 27,69), with a median progression-free survival (PFS) of 9.9 months (95% CI 4.6,14.5) and a median duration of response (DOR) of 10.6 months (95% CI 3.3,12.0).
For the 54 patients evaluable for response, the confirmed ORR was 43 percent (95% CI 29,57), with a median PFS of 7.8 months (95% CI 5.6,10.2); patients in this cohort had received a median of 3 prior lines of systemic therapy, with 58 percent of patients having received prior bevacizumab.
The combination continues to display a safety profile in-line with the known profiles of each agent, with no new safety signals identified.
"The mirvetuximab and Avastin combination has demonstrated very encouraging initial clinical activity in ovarian cancer patients and a consistently favorable safety profile," stated David O’Malley, M.D., Professor, Director of Gynecology Clinical Trial and Phase 1 Program, James Cancer Center and The Ohio State University Wexner Medical Center, and FORWARD II Investigator. "There is a significant need for new therapeutic options to improve outcomes and tolerability for this difficult-to-treat patient population, and I believe these results support further clinical evaluation of this combination regimen."

ASCO PRESENTATION DETAILS
Title: Mirvetuximab soravtansine, a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC), in combination with bevacizumab in patients (pts) with platinum-resistant ovarian cancer: maturing safety and activity profile from the FORWARD II Phase 1b study
Presenter: David M. O’Malley, MD, The Ohio State University College of Medicine
Day/Time: Monday, June 4, 1:15-4:45 pm CDT
Location: Hall A
Abstract: 5549

Additional information, can be found at www.asco.org.

UPDATED DATA FROM FORWARD II DOSE-ESCALATION COHORT WITH CARBOPLATIN
Initial findings from a dose escalation cohort of mirvetuximab in combination with carboplatin were presented at ASCO (Free ASCO Whitepaper) 2017. The data have matured and updated findings in heavily pre-treated patients with platinum-sensitive ovarian cancer include:

In the subset of 10 patients with medium or high FRα expression levels, the confirmed ORR was 80 percent (95% CI 44,98), with a median PFS of 15 months (95% CI 9.9,-), and with median DOR not reached.
For all 17 evaluable patients, the confirmed ORR was 71 percent (95% CI 44,90), with a median PFS of 15 months (95% CI 9.9, -), and with median DOR not reached; 50 percent of patients in this cohort had received 3 or more prior lines of systemic therapy.
The combination continues to display a favorable safety profile in-line with the known profiles of each agent, with no new safety signals identified.
Based on the findings from the carboplatin and Avastin cohorts, ImmunoGen recently initiated an additional cohort assessing a triplet combination of mirvetuximab plus carboplatin and Avastin in patients with recurrent platinum-sensitive ovarian cancer as part of the FORWARD II trial.

DATA FROM FORWARD II DOSE-ESCALATION COHORT WITH KEYTRUDA
Additionally, ImmunoGen recently announced encouraging activity and favorable tolerability data from the FORWARD II cohort assessing mirvetuximab in combination with Merck’s anti-PD-1 therapy Keytruda (pembrolizumab) in patients with platinum-resistant ovarian cancer at the Society of Gynecologic Oncology Annual Meeting. Based on these data, ImmunoGen is completing enrollment in an expansion cohort that includes an additional 35 patients with medium or high FRα expression levels. ImmunoGen plans to report initial findings from this cohort in the second half of this year.

CONFERENCE CALL INFORMATION
ImmunoGen will host a conference call on Thursday, May 17 at 8:00am ET to discuss new data from the FORWARD II trial. To access the live call by phone, dial 323-794-2423; the conference ID is 5718620. The call may also be accessed through the "Investors" section of the Company’s website, www.immunogen.com. Following the live webcast, a replay of the call will be available at the same location through June 7, 2018.

ABOUT FORWARD II
FORWARD II is a Phase 1b/2 study of mirvetuximab in combination with Avastin (bevacizumab), carboplatin or Keytruda (pembrolizumab) in patients with FRα-positive platinum-resistant ovarian cancer, primary peritoneal, or fallopian tube tumors, as well as a triplet combination of mirvetuximab plus carboplatin and Avastin in patients with platinum-sensitive ovarian cancer.

ABOUT MIRVETUXIMAB SORAVTANSINE
Mirvetuximab soravtansine (IMGN853) is the first folate receptor alpha (FRα)-targeting ADC. It uses a humanized FRα-binding antibody to target the ADC specifically to FRα-expressing cancer cells and a potent anti-tumor agent, DM4, to kill the targeted cancer cells.

Galera Therapeutics Announces Presentation of Data from Phase 2b Clinical Trial of GC4419 at 2018 American Society of Clinical Oncology (ASCO) Annual Meeting

On May 16, 2018 Galera Therapeutics, Inc., a clinical-stage biotechnology company developing drugs targeting oxygen metabolic pathways with the potential to transform cancer radiotherapy, reported that data from its Phase 2b clinical trial of GC4419 for severe oral mucositis in patients with head and neck cancer will be presented during an oral abstract session at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to be held June 1-5, 2018 in Chicago (Press release, Galera Therapeutics, MAY 16, 2018, View Source [SID1234526703]). GC4419 is a highly selective and potent small molecule dismutase mimetic that rapidly converts superoxide to hydrogen peroxide and oxygen.

Presentation details are as follows:

Title: Results of a randomized, placebo (PBO) controlled, double-blind P2b trial of GC4419 (avasopasem manganese) to reduce duration, incidence and severity and delay onset of severe radiation-related oral mucositis (SOM) in patients (pts) with locally advanced squamous cell cancer of the oral cavity (OC) or oropharynx (OP)

Abstract Number: 6006

Oral Abstract Session: Head and Neck Cancer

Date / Time / Location: June 3, 2018 / 10-10:12 a.m. CDT / McCormick Place E451

Presenter: Carryn M. Anderson, MD, Radiation Oncologist, University of Iowa Hospitals and Clinics

The abstract has also been selected for inclusion in the 2018 Best of ASCO (Free ASCO Whitepaper) program, which aims to increase global access to cutting-edge science by condensing highlights from ASCO (Free ASCO Whitepaper)’s Annual Meeting into a two-day program to be held this summer.

For information about the 2018 ASCO (Free ASCO Whitepaper) Annual Meeting, please visit View Source

About GC4419

GC4419 is a highly selective and potent small molecule dismutase mimetic that closely mimics the activity of human superoxide dismutase enzymes. GC4419 works to reduce elevated levels of superoxide caused by radiation therapy by rapidly converting superoxide to hydrogen peroxide and oxygen. Left untreated, elevated superoxide can damage noncancerous tissues and lead to debilitating side effects, including oral mucositis (OM), which can limit the anti-tumor efficacy of radiation therapy. Conversion of elevated superoxide to hydrogen peroxide, which is selectively more toxic to cancer cells, can also enhance the effect of radiation on tumors, particularly with stereotactic body radiation therapy (SBRT), which produces high levels of superoxide.

GC4419 has been studied in patients with head and neck cancer, GC4419’s lead indication, for its ability to reduce the duration, incidence and severity of radiation-induced severe oral mucositis (SOM). Results from Galera’s 223-patient, double blind, randomized, placebo-controlled Phase 2b clinical trial demonstrated GC4419’s ability to dramatically reduce the duration of SOM from 19 days to 1.5 days (92 percent), the incidence of SOM through completion of radiation by 34 percent and the severity of patients’ OM by 47 percent, while demonstrating acceptable safety when added to a standard radiotherapy regimen. In addition, in multiple preclinical studies, GC4419 demonstrated an increased tumor response to radiation therapy while preventing toxicity in normal tissue.

The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to GC4419 for the reduction of the duration, incidence and severity of SOM induced by radiation therapy with or without systemic therapy. The FDA also granted Fast Track designation to GC4419 for the reduction of the severity and incidence of radiation and chemotherapy-induced OM.