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Merrimack to Present on Extensive Oncology Pipeline at the 2016 American Society of Clinical Oncology Annual Meeting

On May 18, 2016 Merrimack Pharmaceuticals, Inc. (Nasdaq:MACK) reported that it will present on its extensive oncology pipeline at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, June 3-7, 2016 at McCormick Place, Chicago, Illinois (Press release, Merrimack, MAY 18, 2016, View Source [SID:1234512580]). Final results from a Phase 1 study evaluating the safety, pharmacology and initial efficacy of MM-151 will be presented in a Poster Discussion Session. Merrimack will also present on the results from its Phase 3 NAPOLI-1 study of ONIVYDE, as well as on multiple therapeutic candidates from its antibody engineering and antibody-directed nanotherapeutic (ADN) technology platforms in six poster sessions.

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Poster Discussion Session:

Final results of a first-in-human study evaluating the safety, pharmacology and initial efficacy of MM-151, an oligoclonal anti-EGFR antibody in patients with refractory solid tumors (Abstract 2518)
Session Title: Poster Discussion Session, Developmental Therapeutics – Clinical Pharmacology and Experimental Therapeutics
Sunday, June 5, 2016, 11:30 AM – 12:45 PM CT
Location: Arie Crown Theater

Poster Sessions:

Updated overall survival (OS) analysis of NAPOLI-1: Phase 3 study of nanoliposmal irinotecan (nal-IRI, MM-398), with or without 5-fluorouracil and leucovorin (5-FU/LV), vs 5-FU/LV in metastatic pancreatic cancer (mPAC) previously treated with gemcitabine-based therapy (Abstract 4126)
Session Title: Gastrointestinal (Noncolorectal) Cancer
Saturday, June 4, 2016, 8:00 AM – 11:30 AM CT
Location: Hall A

Randomized Phase 2 study of paclitaxel (PTX), trastuzumab (T) with or without MM-111 in HER2 expressing gastroesophageal cancers (GEC) (Abstract 4043)
Session Title: Gastrointestinal (Noncolorectal) Cancer
Saturday, June 4, 2016, 8:00 AM – 11:30 AM CT
Location: Hall A

A Phase 1b/2 study combining MM-151 + nal-IRI + 5-FU + leucovorin in RAS-wild type metastatic colorectal cancer (mCRC) (Abstract TPS3633)
Session Title: Gastrointestinal (Colorectal) Cancer
Saturday, June 4, 2016, 8:00 AM – 11:30 AM CT
Location: Hall A

SHERLOC: A Phase 2 study of seribantumab (MM-121) in combination with docetaxel or pemetrexed versus docetaxel or pemetrexed alone in patients with heregulin positive (HRG+), locally advanced or metastatic non-small cell lung cancer (NSCLC) (Abstract TPS9110)
Session Title: Lung Cancer – Non-Small Cell Metastatic
Saturday, June 4, 2016, 8:00 AM – 11:30 AM CT
Location: Hall A

HERMIONE: A Phase 2, randomized, open label trial comparing MM-302 plus trastuzumab with chemotherapy of physician’s choice plus trastuzumab, in anthracycline naive HER2-positive, locally advanced/metastatic breast cancer patients previously treated with pertuzumab and ado-trastuzumab emtansine (T-DM1) (Abstract TPS631)
Session Title: Breast Cancer – HER2/ER
Sunday, June 5, 2016, 8:00 AM – 11:30 AM CT
Location: Hall A

A Phase 1 biomarker-directed multi-arm study evaluating the co-administration of MM-151 with MM-121, MM-141, or trametinib in EGFR-driven cancers (Abstract TPS11619)
Session Title: Tumor Biology
Monday, June 6, 2016, 1:00 PM – 4:30 PM CT
Location: Hall A

ImmunoGen Reports Efficacy and Safety Data from a 46-Patient Cohort of Mirvetuximab Soravtansine in FR?-Positive Ovarian Cancer

On May 18, 2016 ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company developing novel antibody-drug conjugate (ADC) cancer therapeutics, reported the clinical data from a 46-patient Phase 1 cohort evaluating the efficacy and safety of mirvetuximab soravtansine as single-agent therapy for platinum-resistant, folate receptor alpha (FRα)-positive ovarian cancer (Press release, ImmunoGen, MAY 18, 2016, View Source [SID:1234512578]). These results have informed the Company’s selection of the patient population and primary endpoint for a Phase 3 study scheduled to begin before year-end.

This Phase 1 cohort, which was expanded from 20 to 46 patients to provide additional information for the design of subsequent trials, enrolled patients with platinum-resistant ovarian cancer who had received up to five previous treatment regimens. Patients also needed to have FRα expressed at or above a predefined level on at least 25% of tumor cells. Patients were classified as having low, medium, or high FRα expression based on the percent of tumor cells meeting this criterion (25-49%, 50-74%, and 75-100%, respectively). Among the 46 patients, 23 had high, 14 had medium, and 9 had low expression of FRα. All had previously received platinum and a taxane.

Among all 46 patients, the confirmed objective response rate (ORR) was 26% and median progression-free survival (PFS) was 4.8 months (95% confidence interval, 3.9-5.7 months). Among the 16 patients who received up to three prior regimens and had high or medium FRα expression – the population selected for the planned Phase 3 trial – the ORR was 44% and median PFS was 6.7 months (95% CI, 3.9-11.0 months). For the 30 patients with low FRα and/or who had received four or five prior regimens, ORR was 17% and median PFS was 4.2 months (95% CI, 2.6-5.5 months).

Current single-agent therapies for platinum-resistant ovarian cancer typically have an ORR of 15-20% and median PFS of 3-4 months, including in patients receiving no more than two prior regimens.1

Based upon the findings in this Phase 1 cohort, the planned Phase 3 trial assessing mirvetuximab soravtansine as single-agent therapy for platinum-resistant ovarian cancer will enroll patients who previously received up to three treatment regimens and whose cancer has high or medium FRα expression, with PFS as the primary endpoint.

"There is a significant need for new therapies for ovarian cancer," commented Dr. Kathleen Moore, Christy Everest Endowed Chair in Cancer Research and Director of the Oklahoma TSET Phase I Unit, Stephenson Cancer Center, University of Oklahoma HSC. "We’re excited about the findings with mirvetuximab soravtansine from this study and to be advancing this first-in-class agent into a Phase 3 trial for platinum-resistant ovarian cancer."

"We plan to have Phase 3 testing of mirvetuximab soravtansine up and running by year end," commented Dr. Charles Morris, ImmunoGen’s EVP and Chief Development Officer. "Now that we have the full results from the 46-patient ovarian cancer cohort, we’ve submitted a meeting request to the FDA to discuss our proposed path to approval. This meeting should take place early in 3Q2016, and we are targeting initiation of FORWARD I Phase 3 testing in 4Q2016."

Mirvetuximab soravtansine was generally well tolerated, with most side effects Grade 1 or 2 (least severe grades). Of particular note, incidence of blurred vision was reduced from 55%, mostly Grade 2, in the first 20 patients enrolled to 39%, mostly Grade 1, among the 26 patients added with the expansion of the cohort. Other side effects reported in more than 20% of patients were diarrhea, fatigue, nausea, vomiting, peripheral neuropathy, increased AST, keratopathy, and abdominal pain.

Data Presentation at ASCO (Free ASCO Whitepaper) 2016

"IMGN853 (mirvetuximab soravtansine), a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC): single-agent activity in platinum-resistant epithelial ovarian cancer patients" will be presented in the Gynecologic Cancer Poster Session (Poster Board #390) taking place on Monday, June 6, from 1:00-4:30 pm CT. (Abstract #5567).

About the Planned FORWARD I Phase 3 Trial

The FORWARD I Phase 3 trial is intended to support full marketing approval of mirvetuximab soravtansine for the treatment of patients with platinum-resistant ovarian cancer who previously received up to three treatment regimens for whom single-agent therapy is appropriate. The cancer also must have high or medium FRα expression. ImmunoGen estimates that 5,000-7,000 patients per year (US) meet these criteria.

Patients will be randomized 2:1 to mirvetuximab soravtansine or physician’s choice, which will include pegylated liposomal doxorubicin, topotecan, and weekly paclitaxel.

PFS will be the primary endpoint of the trial. This study also will be powered for separate assessment of the endpoint in the full study population and in the subset with high FRα expression and will include at least 300 patients.

About Mirvetuximab Soravtansine

Mirvetuximab soravtansine (IMGN853) is the first FRα-targeting ADC. It uses a 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.

ImmunoGen is advancing mirvetuximab soravtansine into Phase 3 testing as a single agent for the treatment of platinum-resistant ovarian cancer. The product candidate is also in Phase 1b/2 testing in combination regimens for ovarian cancer.

About Ovarian Cancer and FRα

This year, approximately 22,300 new cases of ovarian cancer will be diagnosed in the US and more than 14,200 women will die from the disease.2 ImmunoGen estimates that 40% of ovarian cancer cases have high FRα expression, 20% have medium, 20% have low, and 20% have very low levels of FRα.

Standard first-line therapy for ovarian cancer is a platinum-based regimen. Once the cancer becomes platinum-resistant, patients may receive single-agent therapy.

Sumitomo Dainippon Pharma announces Clinical Data of Investigational anti-cancer drugs Napabucasin and Amcasertib in Multiple Cancer Types at ASCO 2016

On May 19, 2016 Sumitomo Dainippon Pharma Co., Ltd. (Head Office: Osaka, Japan; President: Masayo Tada; hereinafter called "Sumitomo Dainippon Pharma") reported that clinical data of napabucasin (BBI608) and amcasertib (BBI503) will be presented at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago from June 3 to June 7, 2016 (Press release, Dainippon Sumitomo Pharma, MAY 18, 2016, View Source [SID:1234512577]).

Napabucasin: 6 presentations
1. ABSTRACT #3564, Poster #261: Saturday, June 4 from 8:00 a.m. – 11:30 a.m.: BBI608-246: NCT02024607: Phase Ib extension study of cancer stemness inhibitor BB608 (Napabucasin) administered in combination with FOLFIRI +/- Bevacizumab (Bev) in patients (pts) with advanced colorectal cancer (CRC). The abstract is now available on the official website of ASCO (Free ASCO Whitepaper) (View Source)

2. ABSTRACT #4128, Poster #120: Saturday, June 4 from 8:00 a.m. – 11:30 a.m.: BBI608-118: NCT02231723: A Phase Ib extension study of cancer stemness inhibitor BB608 (Napabucasin) in combination with Gemcitabine and nab-Paclitaxel (nab-PTX) in patients (pts) with metastatic pancreatic cancer. The abstract is now available on the official website of ASCO (Free ASCO Whitepaper) (View Source)

3. ABSTRACT #9093, Poster #416: Saturday, June 4 from 8:00 a.m. – 11:30 a.m.: BBI608-201: NCT01325441: A Phase Ib/II Study of Cancer Stemness Inhibitor Napabucasin (BB608) Combined with Weekly Paclitaxel in Advanced Non-Small Cell Lung Cancer. The abstract is now available on the official website of ASCO (Free ASCO Whitepaper) (View Source)

4. ABSTRACT #1094, Poster #199: Sunday, June 5 from 8:00 a.m. – 11:30 a.m.:BBI608-201: NCT01325441: A Phase Ib/II Study of Cancer Stemness Inhibitor Napabucasin (BB608) Combined with Weekly Paclitaxel in Advanced Triple Negative Breast Cancer. 2 The abstract is now available on the official website of ASCO (Free ASCO Whitepaper) (View Source)

5. ABSTRACT #5578, Poster #401: Monday, June 6 from 1:00 p.m. – 4:30 p.m.:BBI608-118: NCT01325441: A Phase Ib/II Study of Cancer Stemness Inhibitor Napabucasin (BB608) Combined with Weekly Paclitaxel in Platinum Resistant Ovarian Cancer. The abstract is now available on the official website of ASCO (Free ASCO Whitepaper) (View Source)

6. ABSTRACT #TPS4144, Poster #129b: Saturday, June 4 from 8:00 a.m. – 11:30 a.m.:BBI608-336: NCT02178956: The BRIGHTER trial: A phase III randomized double-blind study of BBI-608 + weekly paclitaxel versus placebo (PBO) + weekly paclitaxel in patients (pts) with pretreated advanced gastric and gastro-esophageal junction (GEJ) adenocarcinoma.
The abstract is now available on the official website of ASCO (Free ASCO Whitepaper) (View Source)

Amcasertib: 1 presentation
1. ABSTRACT #6018, Poster #340: Saturday, June 4 from 1:00 p.m. – 4:30 p.m. (Poster Session) Saturday, June 4 from 4:45 p.m. – 6:00 p.m. (Poster Discussion Session):BBI503-101: NCT01781455: Phase I Extension Clinical Study of BB503, a First-in-Class Cancer Stemness Kinase Inhibitor, in Adult Patients with Advanced Head and Neck Cancer.
The abstract is now available on the official website of ASCO (Free ASCO Whitepaper) (View Source)

CTI BioPharma Announces Presentations At The American Society Of Clinical Oncology Annual Meeting

On May 19, 2016 CTI BioPharma Corp. (CTI) (NASDAQ and MTA:CTIC) reported that data highlighting pacritinib, including additional safety and long-term follow up data from the Phase 3 PERSIST-1 clinical trial, will be presented at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting to be held June 3-7 in Chicago, IL (Press release, CTI BioPharma, MAY 18, 2016, View Source;p=RssLanding&cat=news&id=2169602 [SID:1234512572]). The abstracts are available on the ASCO (Free ASCO Whitepaper) website at www.asco.org. Details regarding the poster presentations, which will include additional data not available in the abstracts, follow.

Pacritinib (PAC) vs. best available therapy (BAT) in myelofibrosis (MF): Outcomes in patients (pts) with baseline (BL) thrombocytopenia
First Author: Claire Harrison, M.D., Guy’s and St. Thomas’ NHS Foundation Trust, Guy’s Hospital, London, United Kingdom
Date/Time: Monday, June 6 at 8:00 a.m.-11:30 a.m. CT
Poster Discussion Session: Monday, June 6, 11:30 a.m.-12:45 p.m. CT in Room E354b
Location: Hall A
Poster Session: Hematologic Malignancies- Leukemia, Myelodysplastic Syndromes, and Allotransplant
Abstract #7011 / Poster Board #3

Pacritinib (PAC) vs. best available therapy (BAT) in myelofibrosis (MF): 60 week follow-up of the phase III PERSIST-1 trial
First Author: Ruben Mesa, M.D., Mayo Clinic Cancer Center, Chair of the Division of Hematology & Medical Oncology, Mayo Clinic Cancer Center, Scottsdale, AZ
Date/Time: Monday, June 6 at 8:00 a.m.-11:30 a.m. CT
Location: Hall A
Poster Session: Hematologic Malignancies- Leukemia, Myelodysplastic Syndromes, and Allotransplant
Abstract #7065 / Poster Board #57

Outcomes in patients with myelofibrosis and RBC-transfusion dependence in the phase III PERSIST-1 study of pacritinib vs. best available therapy
First Author: Claire Harrison, M.D., Guy’s and St. Thomas’ NHS Foundation Trust, Guy’s Hospital, London, United Kingdom
Date/Time: Monday, June 6 at 8:00 a.m.-11:30 a.m. CT
Location: Hall A
Poster Session: Hematologic Malignancies- Leukemia, Myelodysplastic Syndromes, and Allotransplant
Abstract #7066 / Poster Board #58

Pacritinib (PAC) vs. best available therapy (BAT) in myelofibrosis (MF): Long-term follow-up of patient-reported outcomes (PROs) in the phase III PERSIST-1 trial
First Author: Ruben Mesa, M.D., Mayo Clinic Cancer Center, Chair of the Division of Hematology & Medical Oncology, Mayo Clinic Cancer Center, Scottsdale, AZ
Date/Time: Monday, June 6 at 8:00 a.m.-11:30 a.m. CT
Location: Hall A
Poster Session: Hematologic Malignancies- Leukemia, Myelodysplastic Syndromes, and Allotransplant
Abstract #7067 / Poster Board #59

About Pacritinib

Pacritinib is an investigational oral kinase inhibitor with specificity for JAK2, FLT3, IRAK1 and CSF1R. In August 2014, pacritinib was granted Fast Track designation by the FDA for the treatment of intermediate and high risk myelofibrosis including, but not limited to, patients with disease-related thrombocytopenia (low platelet counts); patients experiencing treatment-emergent thrombocytopenia on other JAK2 inhibitor therapy; or patients who are intolerant of, or whose symptoms are not well controlled (sub-optimally managed) on other JAK2 therapy. Clinical studies for pacritinib are currently subject to a full clinical hold issued by the U.S. Food and Drug Administration in February 2016.

CTI BioPharma and Baxalta Incorporated are parties to a worldwide license agreement to develop and commercialize pacritinib. CTI BioPharma and Baxalta will jointly commercialize pacritinib in the U.S. while Baxalta has exclusive commercialization rights for all indications outside the U.S.

Bayer Confirms Preliminary Discussion Regarding Acquisition of Monsanto

On May 19, 2016 Bayer reported that executives recently met with executives of Monsanto to privately discuss a negotiated acquisition of Monsanto Company (Press release, Bayer, MAY 18, 2016, View Source [SID:1234512567]).

The proposed combination would reinforce Bayer as a global innovation-driven Life Science company with leadership positions in its core segments, and would create a leading integrated agriculture business.

This statement follows Monsanto’s announcement earlier today regarding a proposal from Bayer. A further statement will be made as appropriate.