On June 3, 2019 Constellation Pharmaceuticals, Inc. (Nasdaq: CNST), a clinical-stage biopharmaceutical company using its expertise in epigenetics to discover and develop novel therapeutics, reported the presentation of updated interim data from MANIFEST, the Company’s Phase 2 clinical trial of CPI-0610 in MF (Press release, Constellation Pharmaceuticals, JUN 3, 2019, View Source [SID1234536803]). The interim data, which highlight the tolerability and potentially disease-modifying activity of CPI-0610, were presented in a poster at the annual meeting of the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) in Chicago.

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"We are excited by these interim data from the MANIFEST trial, which indicate that CPI-0610 is generally well-tolerated and showed signs that it is an active therapeutic agent for the treatment of myelofibrosis, both as a monotherapy and in combination with a standard-of-care JAK inhibitor," said Adrian Senderowicz, M.D., Chief Medical Officer at Constellation Pharmaceuticals. "Moreover, as these data highlight improvements across key hallmarks of myelofibrosis, we believe that CPI-0610 has the potential to address a broad range of unmet needs in patients with this difficult-to-treat cancer. We look forward to the continued evaluation of CPI-0610 in this ongoing Phase 2 trial and to providing additional data from MANIFEST later this year."

The data were gathered from 44 patients enrolled as of April 17, 2019. Twelve patients received 24-week assessments and 16 patients received 12-week assessments. Below is a summary of results from the interim update across primary and secondary endpoints from the trial:

14 of 16 evaluable patients demonstrated spleen volume reductions. Overall, the median best on-trial spleen volume change from baseline was -19.2%.

Of these 16 evaluable patients, 11 were evaluable for improvement in Total Symptom Score (TSS) according to the Myelofibrosis Symptom Assessment Form, Version 4.0. Six of the 11 (55%) evaluable patients achieved greater than 50% TSS improvement from baseline as a best response.

All of these 16 patients were evaluable for Patient Global Impression of Change (PGIC). Fifteen of 16 (94%) evaluable patients reported improvements in PGIC, of which 10 reported feeling either "much improved" or "very much improved" and no patients reported feeling worse following treatment.

Of 12 evaluable patients who received at least 24 weeks of treatment, three were severely anemic and dependent on red-blood-cell transfusions at baseline. Of these three patients, two converted to transfusion independence. These two patients have remained transfusion independent for more than 69 and 24 weeks, respectively, as of April 17, 2019, and remain on trial.

Ten patients were evaluable for bone marrow fibrosis, of which six (60%) experienced improvement in bone marrow morphology of at least one point on a scale of 0-3. Four of these six patients exhibited improvements within six months of starting CPI-0610 therapy.
Based on the interim data, CPI-0610 was generally well-tolerated, both as a monotherapy and in combination with ruxolitinib. Overall, the most commonly reported side effects (≥10%) were diarrhea, vomiting, upper respiratory tract infection, headache, epistaxis, fatigue, dysgeusia, cough and pruritis. Grade 3 or greater treatment-emergent adverse events were only reported in the combination arm, and those reported in more than one patient included thrombocytopenia, anemia, and decreased platelet counts, each of which was reported in two patients. There was one patient death, which the Company assessed as unlikely to have been related to CPI-0610. The combination therapy of CPI-0610 and ruxolitinib showed a non-cumulative, manageable, and mostly reversible asymptomatic thrombocytopenia.

Each of the first four patients enrolled in MANIFEST, of which two received CPI-0610 as a monotherapy and two received CPI-0610 in combination with ruxolitinib, remained on therapy and had been treated for approximately 16 and 20 months, respectively, as of April 17, 2019.

Please see the poster in the Investors & Media section of Constellation’s website for additional details.

As previously announced in November 2018, Constellation expanded the MANIFEST trial to include a third cohort, designed to evaluate CPI-0610 in combination with ruxolitinib as a first-line therapy in JAK-inhibitor-naïve patients with advanced MF. The Company has begun treating patients in this arm of the trial and expects to provide initial results from this cohort, as well as additional data from the ruxolitinib-resistant and -refractory (second-line) cohorts, in the fourth quarter of 2019.

Investor Event

Constellation will host an analyst/investor meeting, with an accompanying conference call and webcast, to discuss this interim update in the Jackson Park D room at Hyatt Regency McCormick Place in Chicago at 8:00 AM EDT/7:00 AM CDT on June 4, 2019. The agenda of the meeting will include:

An overview of myelofibrosis (MF) and the potential impact of Constellation’s BET inhibitor CPI-0610 in treating MF
A review of the interim data from the MANIFEST clinical trial presented in a poster at ASCO (Free ASCO Whitepaper) on June 3
A panel discussion with two key opinion leaders in MF:
Dr. Srdan Verstovsek, a medical oncologist at the University of Texas MD Anderson Cancer Center and an investigator in the MANIFEST trial; and
Dr. Raajit Rampal, a hematologic oncologist at Memorial Sloan Kettering Cancer Center
The event will be webcast live and can be accessed on the Investor Relations section of Constellation’s website at View Source Participants may also access the event and participate in the live question-and-answer session by dialing (877) 473-2077 (domestic) or (661) 378-9662 (international) and referring to conference ID 1295319.

Medical Presentation at EHA (Free EHA Whitepaper)

Dr. Ronald Hoffman of Mt. Sinai Health System, an investigator in the MANIFEST trial, will make an oral presentation on this interim update of MANIFEST at the European Hematology Association (EHA) (Free EHA Whitepaper) annual meeting at 12:15 PM CEST/6:15 AM EDT on June 15, 2019. Slides from the presentation will be posted to Constellation’s website.

About MANIFEST

MANIFEST is an open-label Phase 2 clinical trial of CPI-0610 in patients with myelofibrosis (MF), a rare cancer of the bone marrow that disrupts the body’s normal production of blood cells. Constellation is evaluating CPI-0610, either as a monotherapy or in combination with ruxolitinib, in a second-line setting in patients with MF who are refractory to or intolerant of or have relapsed or lost response to ruxolitinib. Patients in the two second-line arms are being stratified based on transfusion-dependent status. The primary endpoint for the cohorts with transfusion-dependent patients is conversion to transfusion independence for 12 consecutive weeks. The primary endpoint for the patients who were not transfusion-dependent at baseline is spleen volume reduction. In addition, the Company added a third arm designed to evaluate treatment with CPI-0610 in combination with ruxolitinib as a first-line therapy in JAK-1/2-inhibitor-naïve MF patients.

On June 3, 2019 Oncology Venture A/S ("OV" or "the Company") reported that the FDA has given its initial response to the Company’s IND application and proposed pivotal Phase 3 study of LiPlaCis in the US (Press release, Oncology Venture, JUN 3, 2019, View Source [SID1234536822]). The FDA has requested some additional testing of the LiPlaCis related to the product characterization. Oncology Venture expects to have these additional tests completed in good time before initiation of the study. Oncology Venture will in parallel modify the study design to accommodate FDA’s recommendation for the pivotal study. The earlier communicated timeline for the development of the LiPlaCis is unchanged.

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The LiPlaCis pivotal Phase 3 study in the US will, in similarity to the ongoing Danish Phase 2 trial evaluate LiPlaCis and its companion diagnostic LiPlaCis-DRP for the treatment of metastatic breast cancer. The protocol will be upgraded from a single arm study to a randomized study and the number of patients is expected to be around 200 as previously communicated. The new design is also expected to comply with the requirements that the European Medicines Agency, EMA, has on registrational studies.

LiPlaCis is an intelligent, target controlled liposome formulation of one of the world’s most widely used chemotherapies, cisplatin. The specific LiPlaCis formulation allows delivery of LiPlaCis directly at tumor site. Oncology Ventures drug specific diagnostic tool DRP selects the patients whom are expected to benefit from the treatment. LiPlaCis is showing promising results in an ongoing Phase 2 study in patients with metastatic breast cancer.

"As expected, there will always be questions to a registrational study. Upon the useful feedback from the FDA we will design a randomized study, and we are confident that we can deliver the requested product characterization information allowing us to keep the timelines. The ongoing Phase 2 study in Denmark is showing strong results. The OV team has taken advantage of the DRP technology as a differentiating factor and moved this project forward from a phase 1 study to a registrational study in only two years," says Peter Buhl Jensen, M.D., CEO of Oncology Venture.

For further information, please contact:

For investor inquiries
Ulla Hald Buhl, IR & Communications
E-mail: [email protected]
Telephone +45 21 70 10 49 For media inquiries
Thomas Pedersen, Carrotize PR & Communications
E-mail: [email protected]
Telephone +45 60 62 93 90

On June 3, 2019 Rainier Therapeutics, Inc., a privately held clinical stage drug development company, reported the first interim analysis results from its ongoing FIERCE-22 trial of vofatamab in patients with metastatic bladder cancer (Press release, Rainier Therapeutics, JUN 3, 2019, View Source [SID1234536840]). Results were presented at the 2019 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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FIERCE-22 is a Phase 1b/2 trial evaluating vofatamab, a FGFR3-targeted antibody, in combination with pembrolizumab, an immune checkpoint inhibitor, to determine safety, tolerability and preliminary efficacy in the treatment of patients with locally advanced or metastatic bladder cancer who have progressed following platinum-based chemotherapy and who have not received prior immune checkpoint inhibitor therapy.

The first interim analysis included data from 28 patients enrolled in the Phase 2 trial, which has a targeted total enrollment of approximately 74 patients. Results demonstrate that treatment with vofatamab and pembrolizumab was well tolerated. Five patients discontinued the study due to treatment emergent adverse events, none related to vofatamab. No dose reductions of vofatamab occurred.

An overall best response rate of 36 percent (8/22) was observed in patients with lesions evaluable by RECIST1.1 criteria, 7/22 (32%) were confirmed. Response rates were similar in both wild type and mutant fusion patients (33% and 43%, respectively). A majority of patients have received at least 8 cycles of therapy (1 cycle=21 days). Responses were notably increased in patients with luminal biology (6 of 9 patients). Paired biopsy data from this trial were recently presented at AACR (Free AACR Whitepaper) "Frontiers in Bladder Cancer" (see poster) showing vofatamab induced immune and inflammatory changes in patients with responses.

"These data provide very encouraging clinical evidence of the effect of vofatamab, an antibody targeted against both wild type and mutated FGFR3, in combination with pembrolizumab. Earlier results from this biopsy-driven trial suggested these responses in the wild type FGFR3 patient cohort occurred in urothelial cancers of luminal subtype which typically have immunologically cold tumors. Biopsies obtained post lead-in treatment with vofatamab showed upregulation of genes associated with an inflammatory response," said Arlene O. Siefker-Radtke, MD, The University of Texas MD Anderson Cancer Center. "Further studies are needed to understand the impact of FGFR3 inhibition in urothelial cancer."

"The evidence demonstrated vofatamab provided similar clinical benefits in these patients regardless of FGFR3 tumor status. We plan to continue the enrollment of both wild-type and mutant/fusion patients, and to complete the ongoing Phase 2 trial," said Esteban Abella, MD, Chief Medical Officer of Rainier Therapeutics.

In addition, results were presented from the Phase 2 portion of the FIERCE-21 trial evaluating vofatamab in combination with docetaxel and vofatamab as monotherapy in patients with locally advanced or metastatic bladder cancer with FGFR3 mutations or gent fusions who have relapsed after or are refractory to at least one prior line of chemotherapy. Data presented indicated vofatamab alone and in combination was well tolerated, with no observed long-term safety issues. Vofatamab monotherapy demonstrated single-agent activity in heavily pre-treated patients. In addition, a substantial portion of patients demonstrated long-term benefit from monotherapy and combination therapy.

About Vofatamab

Vofatamab (formerly B-701) is an antibody specifically targeted against the fibroblast growth factor receptor 3 (FGFR3), a known driver of bladder and potentially other FGFR-driven cancers. Vofatamab is the most advanced targeted antibody specific for FGFR3 known by Rainier Therapeutics to be in clinical development. Vofatamab is currently being evaluated in two clinical trials: FIERCE-22 and FIERCE-21.

On June 3, 2019 Nordic Nanovector ASA (OSE: NANO) reported that the European Patent Organisation (EPO) has granted the company’s European Patent covering the use of Betalutin or Humalutin in combination with anti-CD20 antibodies for the treatment of non-Hodgkin’s lymphoma (NHL) (Press release, Nordic Nanovector, JUN 3, 2019, View Source [SID1234553449]). The same patent has also been issued in Japan, China, Australia, Hong Kong, Israel, Russia and Singapore while the patent is pending in USA, Brazil, Canada, Indonesia, India, Korea, Mexico, New Zealand, Philippines, Ukraine and South Africa.

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This patent is a result of Nordic Nanovector’s continued focus on securing intellectual property rights on its pipeline of novel CD37-targeting drug candidates.

Patents covering Betalutin and Humalutin, as well as their medical applications have already been granted in Europe, USA, Canada, China, Hong Kong, Australia, Indonesia, Israel, Japan, Korea, Mexico, New Zealand, Philippines, Russia, Singapore, Ukraine and South Africa. India, Brazil and Thailand are expected to be granted soon.

Finally, two newer patent applications related to Betalutin’s clinical applications and combination with other drugs have also been filed. The latest application has been made public on the 31 May under WO/2019/101789.

On June 3, 2019 Seattle Genetics, Inc. (Nasdaq:SGEN) reported additional analyses of results from ECHELON-1 and ECHELON-2, the frontline phase 3 trials of ADCETRIS (brentuximab vedotin), at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place May 31 to June 4, 2019 in Chicago (Press release, Seattle Genetics, JUN 3, 2019, View Source [SID1234536823]). The ECHELON-1 analysis highlights a three-year update of this phase 3 clinical trial evaluating ADCETRIS in combination with AVD (Adriamycin, vinblastine and dacarbazine) compared to ABVD (Adriamycin, bleomycin, vinblastine and dacarbazine) in stage III or IV frontline classical Hodgkin lymphoma (HL) patients, including analyses by cycle 2 PET (PET2) status and in patients less than 60 years old. In addition, two poster presentations evaluate CD30 expression and response to ADCETRIS treatment in the ECHELON-2 phase 3 clinical trial in peripheral T-cell lymphomas (PTCL) and an analysis of five additional trials in T-cell and B-cell non-Hodgkin lymphomas (NHL). ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical HL and expressed on the surface of several types of PTCL.

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"We continue to evaluate ADCETRIS as the foundation of care for patients with CD30-expressing lymphomas," said Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics. "Importantly, the ECHELON-1 three-year analysis presented at this meeting demonstrate a robust and durable treatment benefit of ADCETRIS plus AVD versus ABVD across most subgroups and regardless of PET status. In addition, other ADCETRIS presentations at the ASCO (Free ASCO Whitepaper) Meeting include new analyses evaluating response by CD30 expression across several non-Hodgkin lymphoma studies."

"Tumor expression of CD30 by IHC in B-cell and T-cell non-Hodgkin lymphomas can be quite variable between different patients with the same diagnosis and even between different biopsies within the same patient," said Steven Horwitz, M.D., Department of Medicine, Lymphoma Service, Memorial Sloan Kettering Cancer Center, New York, and an ADCETRIS clinical trial investigator. "In two poster presentations at this year’s ASCO (Free ASCO Whitepaper) Annual Meeting, results of the analyses suggest that a lower limit or threshold of CD30 expression required for efficacy has not been identified and individual patients may experience clinical benefit from brentuximab vedotin regardless of the level of CD30 expression."

Brentuximab Vedotin with Chemotherapy for Stage 3/4 Classical Hodgkin Lymphoma: 3-year Update of the ECHELON-1 Study (Abstract #7532, poster presentation on Monday, June 3, 2019)

This poster presentation examines progression-free survival (PFS) outcomes per investigator assessment in the intent-to-treat population of 1,334 patients at three-years by PET status and in patients less than 60 years old. As previously reported, the ECHELON-1 trial achieved its primary endpoint with the combination of ADCETRIS plus AVD resulting in a statistically significant improvement in modified PFS versus the control arm of ABVD as assessed by independent review facility (IRF; hazard ratio [HR] 0.77; p-value=0.035). Modified PFS was defined as time to progression, death, or evidence of non-complete response after completion of frontline therapy per IRF followed by subsequent anticancer therapy. Key findings from these analyses include:

The three-year PFS for all patients in the ADCETRIS plus AVD arm was 83.1 percent compared to 76 percent in the ABVD arm (HR 0.70), a difference of 7.1 percent.
PFS benefit at three-years for ADCETRIS plus AVD was observed for all patients independent of PET2 status, including in patients who are less than 60 years old.
PET2-negative result was 85.8 percent in the ADCETRIS plus AVD arm compared to 79.5 percent in the ABVD arm (HR 0.69), a difference of 6.3 percent.
PET2-positive result was 67.7 percent in the ADCETRIS plus AVD arm compared to 51.5 percent in the ABVD arm (HR 0.59), a difference of 16.2 percent.
Consistent improvement in PFS was observed among patients treated with ADCETRIS plus AVD compared with ABVD across the majority of pre-specified subgroups, including disease stage, age and prognostic score.
As previously reported at the primary analysis, on the ADCETRIS plus AVD arm, peripheral neuropathy events were observed in 67 percent of patients compared to 43 percent in the ABVD arm. The three-year analysis shows that among patients with peripheral neuropathy, 78 percent of in the ADCETRIS plus AVD arm and 83 percent in the ABVD arm reported complete resolution or improvement at last follow-up.
Response to A+CHP by CD30 Expression in the ECHELON-2 Trial (Abstract #7538, poster presentation on Monday, June 3, 2019)

As previously reported, the ECHELON-2 trial met its primary endpoint with the combination of ADCETRIS plus CHP resulting in a statistically significant improvement in PFS versus the control arm of CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) per Blinded Independent Central Review (HR=0.71; p-value=0.0110). In addition, overall survival in the ADCETRIS plus CHP arm was statistically significant compared to CHOP (HR=0.66; p-value=0.0244). Complete remission (CR) rate (p-value=0.0066) and objective response rate (ORR; p-value=0.0032) for the ADCETRIS plus CHP arm were also significantly increased. CD30 expression is a hallmark of systemic anaplastic large cell lymphoma (sALCL), but it is variably expressed among non-sALCL PTCL subtypes. As a lack of correlation between CD30 expression and response to ADCETRIS has been previously reported, an analysis was conducted to examine response to ADCETRIS plus CHP by CD30 expression in 57 patients with angioimmunoblastic T-cell lymphoma (AITL) and PTCL-not otherwise specified (PTCL-NOS) in the ECHELON-2 study, the two histologies with variable expression. Key findings of this exploratory analysis include:

Among AITL and PTCL-NOS patients, the ORR in patients treated with ADCETRIS plus CHP was independent of the level of CD30 expression. CRs and PRs were observed in patients with all levels of CD30 expression, including those with the lowest level of 10 percent.
The duration of complete response was not associated with CD30 expression level for patients with AITL or PTCL-NOS.
Response to Brentuximab Vedotin by CD30 Expression: Results from Five Trials in PTCL, CTCL, and B-cell Lymphomas (Abstract #7543, poster presentation on Monday, June 3, 2019)

Exploratory analyses were conducted to examine the correlation between pretreatment CD30 expression level and ORR for patients with CD30 expression greater than or equal to 10 percent, less than 10 percent, or undetectable (0 percent) by immunohistochemistry (IHC). This analysis examined CD30 expression levels of 275 patients across five clinical studies in relapsed or refractory PTCL, cutaneous T-cell lymphoma (CTCL), and B-cell NHL. All patients in this analysis were treated with ADCETRIS monotherapy. The key findings include:

Responses were observed with ADCETRIS treatment in patients with all levels of CD30 expression, including in patients with no detectable CD30 expression by IHC.
Response to ADCETRIS was not associated with CD30 expression level.
The U.S. Food and Drug Administration (FDA) approved ADCETRIS in combination with AVD for the treatment of adult patients with previously untreated stage III or IV classical HL in March 2018, based on the results of the ECHELON-1 phase 3 clinical trial. The FDA approved ADCETRIS in combination with CHP (cyclophosphamide, doxorubicin, and prednisone) for the treatment of adult patients with previously untreated sALCL or other CD30-expressing PTCL, including AITL and PTCL-NOS based on the results of the ECHELON-2 phase 3 trial, in November 2018.

About ADCETRIS

ADCETRIS is being evaluated broadly in more than 70 clinical trials in CD30-expressing lymphomas. These include three completed phase 3 trials: ECHELON-2 trial in frontline peripheral T-cell lymphomas, ECHELON-1 in previously untreated Hodgkin lymphoma, and ALCANZA in cutaneous T-cell lymphoma. The CHECKMATE 812 trial of ADCETRIS in combination with Opdivo (nivolumab) for relapsed/refractory Hodgkin lymphoma is ongoing.

ADCETRIS is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics’ proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells.

ADCETRIS injection for intravenous infusion has received FDA approval for six indications in adult patients with: (1) previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone, (2) previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vinblastine, and dacarbazine, (3) cHL at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation, (4) cHL after failure of auto-HSCT or failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates, (5) sALCL after failure of at least one prior multi-agent chemotherapy regimen, and (6) primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy.

Health Canada granted ADCETRIS approval with conditions for relapsed or refractory Hodgkin lymphoma and sALCL in 2013, and non-conditional approval for post-autologous stem cell transplantation (ASCT) consolidation treatment of Hodgkin lymphoma patients at increased risk of relapse or progression in 2017, adults with pcALCL or CD30-expressing MF who have had prior systemic therapy in 2018, and for previously untreated Stage IV Hodgkin lymphoma in combination with doxorubicin, vinblastine, and dacarbazine in 2019.

ADCETRIS received conditional marketing authorization from the European Commission in October 2012. The approved indications in Europe are: (1) for the treatment of adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma following ASCT, or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, (2) for the treatment of adult patients with relapsed or refractory sALCL, (3) for the treatment of adult patients with CD30-positive Hodgkin lymphoma at increased risk of relapse or progression following ASCT, (4) for the treatment of adult patients with CD30-positive cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy and (5) for the treatment of adult patients with previously untreated CD30-positive Stage IV Hodgkin lymphoma in combination with AVD (Adriamycin, vinblastine and dacarbazine).

ADCETRIS has received marketing authorization by regulatory authorities in 72 countries for relapsed or refractory Hodgkin lymphoma and sALCL. See select important safety information, including Boxed Warning, below.

Seattle Genetics and Takeda are jointly developing ADCETRIS. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and Takeda has rights to commercialize ADCETRIS in the rest of the world. Seattle Genetics and Takeda are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs.