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Array BioPharma Announces Additional Median Overall Survival Results of Encorafenib and Binimetinib in Patients with BRAF-mutant Advanced Melanoma

On June 4, 2018 Array BioPharma Inc. (NASDAQ: ARRY) reported updated results from the Phase 3 COLUMBUS trial in BRAF-mutant advanced melanoma (Press release, Array BioPharma, JUN 4, 2018, View Source [SID1234527132]). The results showed median overall survival (mOS) was 33.6 months for patients treated with the combination of encorafenib and binimetinib compared to 16.9 months for patients treated with vemurafenib as a monotherapy. The combination reduced the risk of death compared to treatment with vemurafenib alone [hazard ratio (HR) of 0.61, [95% CI 0.47, 0.79, p <0.0001]. The observed efficacy of vemurafenib in the control arm is also consistent with historical data, providing an additional benchmark for validating the patient population and results observed in COLUMBUS. [1, 2] Further, the two-year OS with combination therapy was 58%. These results will be part of an oral presentation today at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in Chicago, Illinois and have been selected for the "Best of ASCO (Free ASCO Whitepaper)" program.

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Importantly, the presentation will include data showing limited use of post-trial immunotherapy, which is consistent with other published pivotal trials of BRAF and MEK-inhibitors in BRAF-mutant advanced melanoma. [1, 3]

"The data presented today at ASCO (Free ASCO Whitepaper) demonstrate that the use of subsequent immunotherapies was consistent across treatment groups, indicating that these subsequent treatments are unlikely to have contributed to the observed differences in survival," said Keith T. Flaherty, M.D., Director of the Termeer Center for Targeted Therapy, Massachusetts General Hospital Cancer Center and Professor of Medicine, Harvard Medical School. "This further suggests encorafenib and binimetinib could be a promising new treatment option for patients with BRAF-mutant advanced melanoma."

Additionally, the updated median progression-free survival (mPFS) results for patients treated with the combination of encorafenib and binimetinib remained consistent with what was previously reported at 14.9 months versus 7.3 months for patients treated with vemurafenib [HR= 0.51, 95% CI 0.39-0.67; p<0.0001].

As previously reported, the combination of encorafenib and binimetinib was generally well-tolerated. Grade 3/4 adverse events (AEs) that occurred in more than 5% of patients receiving the combination were increased gamma-glutamyltransferase (GGT) (9%), increased blood creatine phosphokinase (CK) (7%) and hypertension (6%). The incidence of selected any grade AEs of special interest, defined based on toxicities commonly associated with commercially available BRAF+MEK-inhibitor treatments for patients receiving the combination of encorafenib and binimetinib included: rash (22%), serous retinopathy including retinal pigment epithelial detachment (20%), pyrexia (18%) and photosensitivity (5%). Full safety results of COLUMBUS Part 1 were published in The Lancet Oncology.

A PDF of the ASCO (Free ASCO Whitepaper) COLUMBUS presentation will be available on Array’s website.

In the COLUMBUS trial, eligible patients were randomized 1:1:1 to receive the combination of encorafenib, 450 mg daily, plus binimetinib, 45 mg twice daily, encorafenib 300 mg daily as a monotherapy, or vemurafenib 960 mg twice daily as a monotherapy.

Data from Array’s partnered programs with AstraZeneca, Genentech and Loxo Oncology were also presented on the Array-invented molecules selumetinib, ipatasertib and LOXO-292, respectively.

Array will host an encore webcast presentation of the COLUMBUS trial data.

Encore Webcast:
Presenter: Keith T. Flaherty, M.D.
Date: Monday, June 4, 2018
Time: 11:15 a.m. Central Time (12:15 p.m. Eastern Time)
Toll-Free: (844) 464-3927
Toll: (765) 507-2598
Pass Code: 9615719

Webcast, including replay and conference call slides: View Source

About Melanoma
Metastatic melanoma is the most serious and life-threatening type of skin cancer and is associated with low survival rates. [4, 5] There are about 200,000 new cases of melanoma diagnosed worldwide each year, approximately half of which have BRAF mutations, a key target in the treatment of metastatic melanoma. [4, 6, 7, 8]

About COLUMBUS
The COLUMBUS trial (NCT01909453) is a two-part, international, randomized, open label Phase 3 trial evaluating the efficacy and safety of the combination of encorafenib and binimetinib compared to vemurafenib and encorafenib monotherapy in 921 patients with locally advanced, unresectable or metastatic melanoma with BRAFV600 mutation. Prior immunotherapy treatment was allowed. Over 200 sites across North America, Europe, South America, Africa, Asia and Australia participated in the trial. Patients were randomized into two parts:

In Part 1, 577 patients were randomized 1:1:1 to receive the combination of encorafenib 450 mg daily and binimetinib 45 mg twice daily (COMBO450), encorafenib, 300 mg daily alone (ENCO 300), or vemurafenib, 960 mg twice daily alone. The dose of encorafenib in the combination arm is 50% higher than the single agent maximum tolerated dose of 300 mg. A higher dose of encorafenib was possible due to improved tolerability when combined with binimetinib. The primary endpoint for the COLUMBUS trial was an mPFS comparison of the COMBO450 arm versus vemurafenib. mPFS is determined based on tumor assessment (RECIST version 1.1 criteria) by a Blinded Independent Central Review (BICR). Secondary endpoints include a comparison of the mPFS of COMBO450 arm to that of ENCO300 and a comparison of overall survival (OS) in patients treated in the COMBO450 arm to that of vemurafenib alone. Results from Part 1 of the COLUMBUS trial, previously published in The Lancet Oncology May 2018, showed that COMBO450 more than doubled mPFS in patients with advanced BRAF-mutant melanoma, with a mPFS of 14.9 months compared with 7.3 months observed with vemurafenib [HR 0.54, (95% CI 0.41-0.71, p<0.0001)]. In the secondary mPFS comparison of COMBO450 to ENCO300, ENCO300 demonstrated a mPFS of 9.6 months [HR 0.75, (95% CI 0.56-1.00, p=0.051)].

In Part 2, 344 patients were randomized 3:1 to receive encorafenib 300 mg daily plus binimetinib 45 mg twice daily (COMBO300) or ENCO300. Part 2 was designed to provide additional data to help evaluate the contribution of binimetinib to the combination of encorafenib and binimetinib.
As the secondary endpoint comparison of mPFS between the COMBO450 arm and ENCO300 arm in Part 1 did not achieve statistical significance, the protocol specified analysis of OS is descriptive.

About Encorafenib and Binimetinib
BRAF and MEK are key protein kinases in the MAPK signaling pathway (RAS-RAF-MEK-ERK). Research has shown this pathway regulates several key cellular activities including proliferation, differentiation, survival and angiogenesis. Inappropriate activation of proteins in this pathway has been shown to occur in many cancers including melanoma and colorectal cancer. Encorafenib is a late-stage small molecule BRAF inhibitor and binimetinib is a late-stage small molecule MEK inhibitor, both of which target key enzymes in this pathway. Encorafenib and binimetinib are being studied in clinical trials in advanced cancer patients, including the Phase 3 COLUMBUS trial and the Phase 3 BEACON CRC trial.

Array BioPharma has exclusive rights to encorafenib and binimetinib in the U.S. and Canada. Array has granted Ono Pharmaceutical exclusive rights to commercialize both products in Japan and South Korea and Pierre Fabre exclusive rights to commercialize both products in all other countries, including Europe, Asia and Latin America. Encorafenib and binimetinib are investigational medicines and are not currently approved in any country.

Adaptimmune Presents Detailed Safety Update from Ongoing MAGE-A10 Pilot Studies at ASCO

On June 4, 2018 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, reported a safety update from its two ongoing pilot studies with SPEAR T-cells targeting MAGE-A10 in non-small cell lung cancer (NSCLC) and the triple tumor study in bladder, melanoma, and head & neck cancers at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting (Press release, Adaptimmune, JUN 4, 2018, View Source;p=RssLanding&cat=news&id=2352954 [SID1234527130]).

"Based on these safety data, we are enrolling patients and dosing at the target dose of one billion transduced cells in both MAGE-A10 studies, and we anticipate response data later this year," said Rafael Amado, Adaptimmune’s Chief Medical Officer. "Given our preclinical validation and safety testing data, as well as available clinical results, we anticipate that MAGE-A10 SPEAR T-cells will continue to have an acceptable safety profile as we dose patients in higher cell dose cohorts."

Safety Update
A safety update from the two ongoing MAGE-A10 pilot studies was presented during a poster session (data cut-off 04 May 2018):

Eight patients in the 100 million cell safety cohorts received MAGE-A10 SPEAR T-cells in the two ongoing pilot studies: 3 in Cohort 1 of the triple tumor study, and 5 in Cohort 1a of the NSCLC study
Out of the eight patients treated in the safety cohorts, seven received 100 million transduced SPEAR T-cells, and one patient in the triple tumor study received 90 million cells
There were no deaths attributable to SPEAR T-cell therapy
To date, there has been no evidence of off-target toxicity
There were two events of cytokine release syndrome (CRS), both in the NSCLC study: one Grade 4 and one Grade 1; both events resolved
The Grade 4 event of CRS was considered a dose limiting toxicity (DLT), at the time, and cohort 1a of the NSCLC study was expanded from 3 to 6 patients
Overall, most adverse events were consistent with those typically experienced by cancer patients undergoing cytotoxic chemotherapy or other cancer immunotherapies
While no anti-tumor effects were observed at the 100 million cell dose level, transduced SPEAR T‑cells cells were detectable in peripheral blood
Although cells were readily detectable, observed SPEAR T-cell peak expansion was approximately tenfold lower than what was seen at doses of at least one billion cells in other studies, such as those with NY-ESO SPEAR T-cells
After review of these initial safety data by the safety review committee (SRC), the decision was made to escalate to the next dose of one billion transduced MAGE-A10 SPEAR T-cells in the triple tumor and the NSCLC study. One billion cells was the therapeutic threshold dose observed with SPEAR T‑cells targeting NY-ESO in the synovial sarcoma pilot study.

Response data from these ongoing studies is anticipated throughout the remainder of 2018.

Overview of Study Designs

Open-label studies of MAGE-A10 SPEAR T-cells in patients with NSCLC; bladder, melanoma, or head & neck cancers (known as ‘the triple tumor study)
Patients are screened under a separate protocol (Screening Protocol: NCT02636855) to identify those who have the relevant HLA-A*02 alleles and MAGE-A10 tumor expression
Both trials are first-in-human studies utilizing a modified 3+3 design with escalating doses of 0.1, 1.0 and 1-6 x 109 transduced SPEAR T-cells to evaluate safety, including DLTs
After completing Group 3 (1-6 x 109 transduced cells), doses up to 10 billion (1.0 x 1010) transduced cells will be included
The DLT observation period was the first 30 days following SPEAR T-cell infusion for each patient in the initial safety cohorts (100 million cells) and is 7 days in subsequent (≥1 billion cells) cohorts
NSCLC Study:
Patients must be at least 18 years of age and have Stage IIIb or IV NSCLC, have failed at least one platinum‑containing regimen (may have received CPIs), have measurable disease, ECOG 0-1, adequate organ function, and be without brain metastases, history of severe autoimmune disease or current uncontrolled illness
The lymphodepletion regimen for patients receiving:
100 million transduced cells was cyclophosphamide alone (1800 mg/m2/day) for 2 days
One billion (1.0 x 109) transduced cells is cyclophosphamide 600mg/m2/day and fludarabine 30 mg/m2/day on Days -7, -6 and -5
One to six billion (1-6 x 109) or up to ten billion (1.0 x 1010) transduced cells is cyclophosphamide 600mg/m2/day on Days -7, -6, -5 and fludarabine 30 mg/m2/day on Days -7, -6, -5, and -4
Efficacy is assessed by response rate, duration of response, progression-free survival, and overall survival at weeks 4, 8, and 12, month 6, and then every 3 months (for 2 years) and then every 6 months until confirmation of disease progression
Triple Tumor Study:
Patients must be at least 18 years of age and have inoperable or metastatic (advanced) urothelial "bladder" cancer, melanoma, or squamous cell head and neck tumors; and, have received standard of care therapies and have progressive disease
The lymphodepletion regimen for patients receiving:
100 million transduced cells was cyclophosphamide 600mg/m2/day and fludarabine 30 mg/m2/day on Days -7, -6 and -5
One billion (1.0 x 109) transduced cells is cyclophosphamide 600mg/m2/day and fludarabine 30 mg/m2/day on Days -7, -6 and -5
One to six billion (1-6 x 109) or up to ten billion (1.0 x 1010) transduced cells is cyclophosphamide 600mg/m2/day on Days -7, -6, -5 and fludarabine 30 mg/m2/day on Days -7, -6, -5, and -4
Efficacy is assessed by overall response rate, best overall response, time to response, duration of response, duration of stable disease, progression-free survival, and overall survival at weeks 6, 12, 18, and 24 weeks, and then every 3 months until confirmation of disease progression
Conference Call Information
The Company will host a live teleconference to answer questions about the updated safety data today, June 4, 2018, at 8:00 a.m. EDT (1:00 p.m. BST). The live webcast of the conference call will be available via the events page of Adaptimmune’s corporate website at https://bit.ly/2shwniM. An archive will be available after the call at the same address. To participate in the live conference call, if preferred, please dial please dial +1-(833) 652-5917 (U.S.) or +1-(430) 775-1624 (International). After placing the call, please ask to be joined into the Adaptimmune conference call and provide the confirmation code (9199456).

MEI Pharma Presents Clinical Data for ME-344 in HER2 Negative Breast Cancer Patients at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting

On June 4, 2018 MEI Pharma, Inc. (Nasdaq: MEIP), a pharmaceutical company focused on leveraging its extensive development and oncology expertise to identify and advance new therapies for cancer, reported that data presented at ASCO (Free ASCO Whitepaper) 2018 from an investigator-initiated study of ME-344 in patients with HER2 negative breast cancer demonstrate evidence of inhibition of tumor proliferation as measured by Ki-67 reductions (Press release, MEI Pharma, JUN 4, 2018, View Source [SID1234527129]). These interim data are consistent with preclinical results indicating ME-344’s potential to reverse resistance to anti-angiogenic therapy, thereby warranting the continuation of the ongoing study.

"The goal of this study is to gain a better understanding of the escape pathways that may be utilized by tumors against antiangiogenic therapeutics. The interim results from this study suggest that there may be an important therapeutic role for mitochondrial inhibitors like ME-344, providing a potential novel mechanism to improve patient outcomes in combination with antiangiogenic therapeutics," stated the study principal investigator, Miguel Quintela-Fandino, M.D., Ph.D., Director of the Clinical Research Program, Centro Nacional De Investigaciones Oncologicas, Madrid, Spain.

"We are looking forward to continuing our work with Dr. Quintela-Fandino as we further elucidate the opportunity to advance ME-344 as part of a novel approach for the treatment of cancer," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma.

The ME-401 ASCO (Free ASCO Whitepaper) 2018 poster can be accessed on the MEI Pharma website.

ME-344 Clinical Data
The ongoing study is a multicenter, investigator-initiated, randomized, open-label, clinical trial evaluating ME-344 in a total of up to 40 patients with HER2-negative breast cancer in combination with the vascular endothelial growth factor inhibitor bevacizumab (marketed as Avastin). Patients are randomized one-to-one to either ME-344 plus Avastin or saline plus Avastin. The interim data review was predefined to take place after 20 patients were randomized.

The primary efficacy endpoint is inhibition of cell proliferation as measured by Ki-67 reductions. Mean absolute (relative) Ki67 decreases were 5.13 (29%) and 1.2 (9%) in the active versus control arms (P=0.06). Patients with standardized uptake values via PET scan ≥ 10% experienced an absolute average Ki67 decrease of 16.6 vs. 2.3 in the active versus control arms (P=0.19). Treatment was generally well tolerated; two Grade 3 adverse events (high blood pressure) were reported, 1 in each arm, and deemed related to bevacizumab.

About ME-344
ME-344 is a novel, tumor selective, isoflavone-derived mitochondrial inhibitor drug candidate. It directly targets the OXPHOS complex 1, a pathway involved in the production of adenosine triphosphate, or ATP, in the mitochondria. Treatment of tumor cells with ME-344 results in a rapid loss of ATP and cancer cell death. ME-344 demonstrated evidence of single-agent activity against refractory solid tumors in a Phase I study, and in preclinical studies, tumor cells treated with ME-344 resulted in a rapid loss of ATP and cancer cell death.

In addition to single-agent activity, ME-344 may also have potential in combination with antiangiogenic therapeutics. While antiangiogenics reduce the rate of glycolysis in tumors as a mechanism to block growth, tumor metabolism often shifts to mitochondrial metabolism to continue energy production to support continued tumor proliferation. In such cases of tumor plasticity in the presence of treatment with antiangiogenics, targeting the alternative metabolic source with ME-344 may open an important therapeutic opportunity.

MEI Pharma Presents Phase 1b Clinical Data for ME-401 in Patients with Indolent B-Cell Malignancies at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting

On June 4, 2018 MEI Pharma, Inc. (NASDAQ: MEIP) a pharmaceutical company focused on leveraging its extensive development and oncology expertise to identify and advance new therapies for cancer, reported that data presented at ASCO (Free ASCO Whitepaper) 2018 from a Phase 1b study of ME-401 demonstrate a 90% objective response rate in patients with relapsed or refractory follicular lymphoma (FL), chronic lymphocytic lymphoma (CLL) and small lymphocytic lymphoma (SLL) (Press release, MEI Pharma, JUN 4, 2018, View Source [SID1234527128]). Based on the data in this program, MEI anticipates progressing into a single-agent registration study later in 2018 for the treatment of adults with relapsed or refractory follicular lymphoma. ME-401 is a next-generation selective oral inhibitor of PI3K delta.

"The clinical evidence we are accumulating from the Phase 1b study of ME-401 is very promising; the data demonstrate a 90% response rate across all patients with relapsed or refractory FL, CLL and SL, and an 86% rate in patients with relapsed or refractory follicular lymphoma," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "There continues to be a need for effective treatment options among patients with relapsed or refractory follicular lymphoma. We therefore anticipate moving into a single-agent registration study by the end of the year"

The ME-401 ASCO (Free ASCO Whitepaper) 2018 poster can be accessed on the MEI Pharma website.

ME-401 Phase 1b Data
ME-401 is being evaluated in a Phase 1b dose escalation study in patients with relapsed or refractory FL, CLL and SLL. As of May 14, 2018, 46 patients were enrolled: 31 patients received monotherapy and 30 were evaluable for efficacy (12 patients at 60 mg, 12 patients at 120 mg and six patients at 180 mg). Based on the data, the Company determined that no further dose escalation was required. An expansion cohort of up to 30 patients with FL, CLL and SLL was added to further evaluate the safety and efficacy of ME-401 as a single agent at the 60 mg dose. An additional 15 patients are enrolled in the study arm evaluating ME-401 (60 mg) in combination with rituximab (marketed as Rituxan) in patients with various B cell malignancies.

ME-401 administered as a single-agent achieved a high response rate of 90% in all evaluable patients as well as a high rate of 86% in the group of patients with FL:

Idera Pharmaceuticals Presents Clinical Data from the ILLUMINATE-204 Trial of the Combination of tilsotolimod and ipilimumab for Anti-PD-1 Refractory Metastatic Melanoma at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting

On June 4, 2018 Idera Pharmaceuticals, Inc. (NASDAQ:IDRA), a clinical-stage biopharmaceutical company developing toll-like receptor and RNA therapeutics for patients with rare cancers and rare diseases, reported results from the ongoing ILLUMINATE-204 trial investigating tilsotolimod, Idera’s intratumorally-delivered Toll-like Receptor (TLR) 9 agonist, in combination with ipilimumab (Yervoy*) (Press release, Idera Pharmaceuticals, JUN 4, 2018, View Source [SID1234527126]). Current data show an overall response rate (ORR) of 38 percent following treatment with the combination of tilsotolimod and ipilimumab. This includes 2 complete responses (1 ongoing for 23 months) and an ongoing PR for 12 months. These results will be presented at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, IL during the poster display session from 1:15-4:45 PM CT and as the subject of a poster discussion session from 4:45-6:00 PM CT.

"We have clinical evidence that tilsotolimod activates both the innate and adaptive immune responses, and when used in combination with a checkpoint inhibitor like ipilimumab, triggers immune responses in previously resistant tumors," stated Adi Diab, M.D., Lead Trial Investigator, Assistant Professor, Department of Melanoma Medical Oncology, Division of Cancer Medicine, University of Texas, MD Anderson Cancer Center. "In patients with metastatic melanoma receiving pembrolizumab who switched to single agent ipilimumab at the time of disease progression the reported ORR was 13%. The ORR of 38% observed in the ILLUMINATE-204 study and the duration of response, which is ongoing in most of the responders, is particularly encouraging and suggests that the combination of tilsotolimod and ipilimumab is a very promising strategy for treating patients with metastatic melanoma whose cancer does not respond to PD-1 therapy alone."

The data available for presentation includes 26 patients whose disease had progressed on anti PD-1 therapy. 21 were evaluable for efficacy [reached first disease assessment as of 09 May 2018], all of whom received tilsotolimod in combination with ipilimumab. The median age of patients at this time is 68.5; 23 of the 26 patients (~88%) had Stage IV melanoma and 11 (42.3%) M1c. 11 of the 26 patients presented with BRAF mutations. The ILLUMINATE-204 trial is planned to enroll up to 60 patients at the 8 mg dose of tilsotolimod, with enrollment completion expected by the end of 2018. Additionally, Idera initiated a global Phase 3 trial of tilsotolimod in combination with ipilimumab (ILLUMINATE-301) compared with ipilimumab alone in anti-PD-1 refractory melanoma in the first quarter of 2018.

ILLUMINATE-204 Key Findings:

21 patients treated with the 8 mg dose of tilsotolimod in combination with ipilimumab have had disease evaluations;
Confirmed RECIST v1.1 responses (including 2 Complete Response [CR]) were observed in 8 of these 21 subjects (38.1%);
Six of 8 responses are ongoing (1 CR ongoing for nearly 2 years); median duration of response for these 8 has not yet been reached;
Overall 15 patients out of 21 evaluable for efficacy (71.4%) experienced disease control (CR, PR, or SD);
The combination regimen is generally well tolerated. 6/26 subjects (23%) had immune-related toxicities indicating that IMO-2125 + ipilimumab does not appear to add toxicity versus ipilimumab alone.
Injection-related toxicities were grade 1-2 transient fever and flu-like symptoms lasting <48 hours; and,
15/26 patients (57.7%) with lesions accessible only by image-guided injection (5 deep visceral lesions and 10 lymph nodes) were included.
Additionally:

A RECIST v1.1 PR of > 2 year duration is ongoing in a patient treated with tilsotolimod 4 mg in combination with ipilimumab; and
A RECIST v1.1 CR is ongoing in a patient treated with tilsotolimod 16 mg in combination with pembrolizumab.
"Patients with melanoma and metastatic disease progressing on anti-PD-1 therapy have limited treatment options and need rapid intervention," stated Joanna Horobin, M.B., Ch.B., Idera’s Chief Medical Officer. "We have previously reported that tilsotolimod produces maturation of pDCs to activate the immune system within 24 hours of dosing to provide a synergistic anti-tumor effect when combined with ipilimumab. The combination is generally well tolerated; specifically less than a quarter of patients experienced immune-related toxicities. Moreover, the ability to safely deliver tilsotolimod into deep visceral lesions and lymph nodes significantly broadens the opportunity to provide this new therapeutic approach to patients. This becomes particularly important as we expand the clinical program of tilsotolimod beyond melanoma to other metastatic tumor types which rarely have superficial lesions available for injection."

A copy of the poster presentation is currently available on Idera’s corporate website at View Source

Two additional abstracts were accepted for publication by the review committee:

Title: Preliminary safety of deep/visceral (D/V) image guided (IG) intratumoral
injection (ITI) of IMO-2125.
Abstract Number
For Publication: e15150
Author: Hani Babiker, MD, University of Arizona Cancer Center

Title: Right tumor, right time: Systematic methodology for fiducial marker
placement to achieve reliable and reproducible image guided (IG)
delivery of intratumoral immunotherapy into deep/visceral (D/V) lesions
and target-lesion imaging follow-up
Abstract Number
For Publication: e24137
Author: Gregory John Woodhead, MD, PhD, University of Arizona Cancer Center
Investor Event and Webcast
The company plans to hold an investor/analyst event at the ASCO (Free ASCO Whitepaper) Annual Meeting on Monday, June 4, 2018, beginning at 6:30 PM CT, which will feature a presentation by ILLUMINATE-204 lead investigator Adi Diab, MD as well as Q&A with attendees and Idera management. As a convenience to those unable to attend in person, the event will be webcast.

The webcast can be accessed live or in archived form in the "Investors" section of the company’s website at www.iderapharma.com. The company plans to post a slide presentation on Monday, June 4, 2018 to the Idera corporate website in the "Investors" section which will be referenced during the conference call.

About Tilsotolimod (IMO-2125)
Tilsotolimod is a TLR 9 agonist that received Fast Track Designation from the US Food and Drug Administration (FDA) in 2017 for the treatment of anti-PD-1 refractory melanoma, in combination with ipilimumab as well as orphan drug designation from the FDA for the treatment of melanoma Stages IIb to IV. It signals the immune system to create and activate cancer-fighting cells (T-cells) to target solid tumors. Currently approved immuno-oncology treatments, specifically check-point inhibitors, work for some but not all, as many patients’ immune response is missing or weak and thus they do not benefit from the checkpoint therapy. Intratumoral injections with tilsotolimod are designed to selectively enable the T-cells to recognize and attack cancers that remained elusive and unrecognized by the immune system exposed to checkpoint inhibitors alone, while limiting toxicity or impact on healthy cells in the body.

About ILLUMINATE-204
The ILLUMINATE-204 study (2125-204) is for patients who have metastatic melanoma for whom treatment with an anti-PD-1 drug like Keytruda** (pembrolizumab) or Opdivo* (nivolumab) has failed. Melanoma is the most dangerous type of skin cancer. When it is metastatic, it means that the melanoma has spread to different parts of the body. ILLUMINATE-204 is a multi-center, two-arm Phase 1/2 study that tests the safety and effectiveness of tilsotolimod in combination with either ipilimumab (Yervoy) or pembrolizumab (Keytruda) for the treatment of patients with anti-PD-1 refractory metastatic melanoma.

For additional details about ILLUMINATE-204, please go to clinicaltrials.gov and search for study identifier NCT02644967.

About ILLUMINATE-301
The ILLUMINATE-301 study (2125-MEL-301) is for patients who have metastatic melanoma for whom treatment with an anti-PD-1 drug like Keytruda (pembrolizumab) or Opdivo (nivolumab) has failed. ILLUMINATE-301 is a global, multi-center, randomized Phase 3 study that compares the effectiveness and safety between two treatment groups: IMO-2125 combined with ipilimumab (Yervoy) versus ipilimumab given alone.

For additional details about ILLUMINATE-301, please go to clinicaltrials.gov and search for study identifier NCT03445533.

About Metastatic Melanoma
Melanoma is a type of skin cancer that begins in a type of skin cell called melanocytes. As is the case in many forms of cancer, melanoma becomes more difficult to treat once the disease has spread beyond the skin to other parts of the body such as the lymphatic system, liver or other visceral organs (metastatic disease). Because melanoma occurs in younger individuals, the years of life lost to melanoma are also disproportionately high when compared with other cancers. Although melanoma is a rare form of skin cancer, it comprises over 75% of skin cancer deaths. The American Cancer Society estimates that there were approximately 76,000 new invasive melanoma cases and 10,000 deaths from the disease in the USA in 2016. Additionally, according to the World Health Organization, about 132,000 new cases of melanoma are diagnosed around the world every year.