On June 24, 2024 IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in advanced development of its non-viral DNA-mediated immunotherapy, reported database lock for its Phase 2 OVATION 2 Study evaluating the safety and efficacy of IMNN-001 in patients with advanced ovarian cancer (Press release, IMUNON, JUN 24, 2024, View Source [SID1234644503]). Median Overall Survival (OS) and Progression Free Survival (PFS) have been reached and all patients in the open-label study have achieved treatment observation duration of 16 months, as required per protocol to evaluate efficacy. The independent statisticians have received the raw trial data and will follow the statistical analysis plan as they analyze the data from the trial. IMUNON expects to report topline results including hazard ratios before the end of July 2024.

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OVATION 2 is evaluating the dosing, safety, efficacy and biological activity of intraperitoneal administration of IMNN-001 in combination with neoadjuvant chemotherapy (NACT) in patients newly diagnosed with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer. Treatment in the neoadjuvant period is designed to shrink the tumors as much as possible for optimal surgical removal after three cycles of chemotherapy. Following NACT, patients undergo interval debulking surgery, followed by three additional cycles of adjuvant chemotherapy to treat any residual tumor. Patients were randomized 1:1 and evaluated for safety and efficacy to compare NACT plus IMNN-001 versus standard-of-care NACT. Patients randomized to the IMNN-001 treatment arm received up to 17 doses of 100 mg/m2, in addition to NACT. Full enrollment of 110 patients was reached in September 2022.

The OVATION 2 Study is meant to inform the design of the intended Phase 3 trial and was not powered for statistical significance. Per the Statistical Analysis Plan (SAP), the primary efficacy analysis will be based on the Intent to Treat (ITT) population. The primary efficacy endpoint is PFS, with secondary endpoints including OS, Objective Response Rate, Chemotherapy Response Score and Surgical Response.

Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON, said, "Reaching data lock for the OVATION 2 Study is a significant achievement for our team and a step forward in our mission to bring an innovative treatment to patients battling ovarian cancer. With the last patient enrolled in September 2022, the analyses generated using the ITT population, an industry gold standard, will now have sufficient data maturity to analyze both PFS and OS endpoints with a good level of confidence. We are hopeful that IMNN-001 will offer improved outcomes and a much-needed alternative to those affected by this deadly disease."

Sebastien Hazard, M.D., Ph.D., chief medical officer of IMUNON, added, "Given the maturity of our data, OS will be important in the readout of the trial and in planning the Phase 3 trial. As the definitive endpoint, OS has been observed across all tumor types as most reflective of the long-term benefit of immunotherapies. We look forward to the trial readout and sharing learnings from the trial with the patient and medical community."

About IMNN-001 Immunotherapy

Designed using IMUNON’s proprietary TheraPlas platform technology, IMNN-001 is an interleukin-12 (IL-12) DNA plasmid vector encased in a nanoparticle delivery system that enables cell transfection followed by persistent, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anticancer immunity acting through the induction of T-lymphocyte and natural killer cell proliferation. IMUNON previously reported positive safety and encouraging Phase 1 results with IMNN-001 administered as monotherapy or as combination therapy in patients with advanced peritoneally metastasized primary or recurrent ovarian cancer, and completed a Phase 1b dose-escalation trial (the OVATION 1 Study) of IMNN-001 in combination with carboplatin and paclitaxel in patients with newly diagnosed ovarian cancer.

About Epithelial Ovarian Cancer

Epithelial ovarian cancer is the fifth deadliest malignancy among women in the United States. There are approximately 22,000 new cases of ovarian cancer every year and approximately 70% are diagnosed in advanced Stage III/IV. Epithelial ovarian cancer is characterized by dissemination of tumor in the peritoneal cavity with a high risk of recurrence (75% in Stage III/IV) after surgery and chemotherapy. Since the five-year survival rates of patients with Stage III/IV disease at diagnosis are poor (41% and 20%, respectively), there remains a need for a therapy that not only reduces the recurrence rate, but also improves overall survival. The peritoneal cavity of advanced ovarian cancer patients contains the primary tumor environment and is an attractive target for a regional approach to immune modulation.

On June 24, 2024 Illumina, Inc. (NASDAQ: ILMN) reported the successful completion of the spin-off of GRAIL (Press release, Illumina, JUN 24, 2024, View Source [SID1234644502]). This milestone follows the company’s previously announced plans to divest GRAIL, and GRAIL is now a public and independent company. GRAIL will begin regular way trading on Nasdaq on Tuesday, June 25 under the ticker symbol "GRAL." Illumina will continue to trade on Nasdaq under the ticker symbol "ILMN."

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"With the completion of the spin-off of GRAIL, we have achieved our goal of divesting GRAIL in a manner that allows its breakthrough technology to continue benefiting patients," said Jacob Thaysen, CEO of Illumina. "Illumina will maintain a minority share of 14.5% in the company. GRAIL plays a critical role in the fight against cancer, and while the company is no longer part of Illumina, we remain confident in its future and will continue to support GRAIL with our sequencing technology, end-to-end workflows, and suite of services."

Later this week, Illumina will file an 8-K/A providing historical unaudited pro forma financial information and will provide supplemental non-GAAP information on its investor relations website at View Source

Illumina also announced it will issue results and host its earnings call for the second quarter of 2024 following the close of market on Tuesday, August 6, 2024. Illumina will also host a virtual Strategy Update on Tuesday, August 13, 2024, beginning at 8:00 am Pacific Time (11:00 am Eastern Time) and running for approximately two hours. Additional details for these events will be announced in the coming weeks and provided on Illumina’s investor relations website, View Source Replays of these events will be posted on Illumina’s investor relations website after each event and for at least 30 days following.

"As we turn the page, we are excited to share our plan to accelerate topline growth, achieve operational excellence, deliver for our customers, and maximize value for shareholders in our upcoming strategy update," said Thaysen. "Illumina is prepared to lead the next era of innovation in next generation sequencing by continuing to focus on strengthening our business and catalyzing the industry with an even greater focus on our customers’ priorities."

Financing Information

As previously disclosed, on June 17, 2024, Illumina entered into a 364-day delayed draw credit agreement that provided for a senior unsecured term loan credit facility in an aggregate principal amount of up to $750 million. The credit facility was drawn in full on June 20, 2024, and the proceeds, together with cash from Illumina’s balance sheet, were used to fund cash to the balance sheet of GRAIL in connection with Illumina’s divestment of GRAIL. The current borrowing rate under the credit facility is approximately 6.70%.

Distribution Details

The separation was achieved through the distribution of 85.5% of the outstanding shares of GRAIL to holders of Illumina common stock at 12:01 a.m. ET on June 24, 2024 (the "Distribution Date"). In addition to retaining their shares of Illumina common stock, Illumina shareholders received one share of GRAIL common stock for every six shares of Illumina stock held as of close of business on the record date of June 13, 2024. Illumina retained 14.5% of the outstanding shares of GRAIL common stock.

On Tuesday, June 25, 2024, the first trading day following the Distribution Date, GRAIL will begin trading "regular way" on Nasdaq under the ticker symbol "GRAL." There will no longer be two markets in Illumina common stock and Illumina will continue to trade on Nasdaq under the ticker symbol "ILMN."

Fractional shares of GRAIL common stock were not distributed to Illumina shareholders and are instead being aggregated and sold in the open market. The net proceeds will be distributed pro rata, in cash, to Illumina shareholders who would otherwise have received a fractional share of GRAIL common stock.

For U.S. federal income tax purposes, Illumina’s U.S. shareholders (other than those subject to special rules) generally should not recognize a gain or loss as a result of the distribution of GRAIL shares, except with respect to cash received in lieu of fractional shares. Illumina shareholders are urged to consult with their tax advisors with respect to the U.S. federal, state, and local or foreign tax consequences, as applicable, of the spin-off.

For more information about the distribution, please contact the distribution agent, Computershare Trust Company, N.A., at 150 Royall Street, Canton, MA 02021 or at the telephone number 877-373-6374.

On June 24, 2024 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) reported that it will host a R&D update in Shanghai, China, and via webcast on Tuesday, July 9, 2024 (Press release, Hutchison China MediTech, JUN 24, 2024, View Source [SID1234644501]) (Press release, Hutchison China MediTech, JUN 24, 2024, View Source [SID1234644501]).

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During the event, the senior management team will share insights into the Company’s R&D strategy and vision. Additionally, the team will provide updates on certain programs within HUTCHMED’s extensive and innovative pipeline. This will include updates on the Phase III ESLIM‑01 and Phase II/III ESLIM‑02 studies of our Syk inhibitor sovleplenib in immune thrombocytopenia ("ITP") and warm antibody autoimmune hemolytic anemia, ("wAIHA") respectively; the surufatinib Phase II/III study for metastatic pancreatic ductal adenocarcinoma ("PDAC"); and the Phase III RAPHAEL study of our IDH1/2 inhibitor HMPL-306 in acute myeloid leukemia ("AML").

The in-person event will take place from 3:00 p.m. to 5:00 p.m. HKT in Chinese (Putonghua) in Shanghai. A live webcast will be held simultaneously. Attendance for the in-person event is by invitation only.

An English language webcast will take place from 8:30 p.m. HKT / 8:30 a.m. EDT / 1:30 p.m. BST on Tuesday, July 9, for approximately two hours.

Both webcasts will be live and can be accessed via www.hutch-med.com/event. Investors interested in listening to a webcast should log on before the start time to download any software required. A replay of the event will be available shortly thereafter for approximately 90 days.

On June 24, 2024 GSK plc (LSE/NYSE: GSK) reported the European Medicines Agency (EMA) has accepted its application to expand the use of Jemperli (dostarlimab) in combination with standard-of-care chemotherapy (carboplatin and paclitaxel) to all adult patients with primary advanced or recurrent endometrial cancer (Press release, GlaxoSmithKline, JUN 24, 2024, View Source [SID1234644500]). The EMA’s Committee for Medicinal Products for Human Use will begin the formal review process to make a recommendation to the European Commission, with approval expected in H1 2025.

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Currently, in the EU, Jemperli in combination with carboplatin and paclitaxel is approved for the treatment of adult patients who are candidates for systemic therapy with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H). If this new application is approved, dostarlimab would be expanded to all patients with primary advanced or recurrent endometrial cancer, regardless of their biomarker type, including those with mismatch repair proficient (MMRp)/microsatellite stable (MSS) tumours where currently there are no approved frontline immuno-therapy-based treatments in the EU.

The application is based on results from Part 1 of the RUBY phase III trial. The trial met its primary endpoints of investigator-assessed progression-free survival (PFS) and overall survival (OS), demonstrating a statistically significant and clinically meaningful benefit in the overall population of patients treated with dostarlimab plus carboplatin-paclitaxel versus chemotherapy alone. RUBY Part 1 is the only clinical trial to show a statistically significant overall survival benefit in this patient population. The safety and tolerability analyses from RUBY showed a safety profile for dostarlimab plus carboplatin-paclitaxel that was generally consistent with the known safety profiles of the individual agents.

OS data were presented at the Society of Gynecologic Oncology Annual Meeting on Women’s Cancer on 16 March 2024, and were published in Annals of Oncology on 9 June 2024.

About endometrial cancer
Endometrial cancer is found in the inner lining of the uterus, known as the endometrium. Endometrial cancer is the most common gynaecologic cancer in developed countries, with approximately 417,000 new cases reported each year worldwide1, and incidence rates are expected to rise by almost 40% between 2020 and 2040.2,3 In Europe, approximately 121,000 people are estimated to be diagnosed with primary advanced or recurrent endometrial cancer each year.4 Approximately 15-20% of patients with endometrial cancer will be diagnosed with advanced disease at the time of diagnosis.5 Among patients with primary advanced or recurrent endometrial cancer, approximately 70-75% have MMRp/MSS tumours.6

About RUBY
RUBY is a two-part global, randomised, double-blind, multicentre phase III trial of patients with primary advanced or recurrent endometrial cancer. Part 1 is evaluating dostarlimab plus carboplatin-paclitaxel followed by dostarlimab versus carboplatin-paclitaxel plus placebo followed by placebo. Part 2 is evaluating dostarlimab plus carboplatin-paclitaxel followed by dostarlimab plus niraparib versus placebo plus carboplatin-paclitaxel followed by placebo.

In Part 1, the dual-primary endpoints are investigator-assessed PFS based on the Response Evaluation Criteria in Solid Tumours v1.1 and OS. The statistical analysis plan included pre-specified analyses of PFS in the dMMR/MSI-H and overall populations and OS in the overall population. Pre-specified exploratory analyses of PFS and OS in the MMRp/MSS population and OS in the dMMR/MSI-H populations were also performed. RUBY Part 1 included a broad population, including histologies often excluded from clinical trials and had approximately 10% of patients with carcinosarcoma and 20% with serous carcinoma.

In Part 2, the primary endpoint is investigator-assessed PFS in the overall population, followed by PFS in the MMRp/MSS population, and OS in the overall population is a key secondary endpoint. Additional secondary endpoints in Part 1 and Part 2 include PFS per blinded independent central review, PFS2, overall response rate, duration of response, disease control rate, patient-reported outcomes, and safety and tolerability.

RUBY is part of an international collaboration between the European Network of Gynaecological Oncological Trial groups (ENGOT), a research network of the European Society of Gynaecological Oncology (ESGO) that consists of 22 trial groups from 31 European countries that perform cooperative clinical trials, and the GOG Foundation, a non-profit organisation dedicated to transforming the standard of care in gynaecologic oncology.

About Jemperli (dostarlimab)
Jemperli, a programmed death receptor-1 (PD-1)-blocking antibody, is the backbone of GSK’s ongoing immuno-oncology-based research and development programme. A robust clinical trial programme includes studies of Jemperli alone and in combination with other therapies in gynaecologic, colorectal and lung cancers, as well as where there are other opportunities for transformational outcomes. It was the first immuno-oncology treatment approved, in combination with chemotherapy, in the frontline setting for primary advanced or recurrent dMMR/MSI-H endometrial cancer.

In the US, Jemperli is indicated in combination with carboplatin and paclitaxel, followed by Jemperli as a single agent for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is dMMR, as determined by a US FDA-approved test, or MSI-H, and as a single agent for adult patients with dMMR recurrent or advanced endometrial cancer, as determined by a US FDA-approved test, that has progressed on or following a prior platinum-containing regimen in any setting and are not candidates for curative surgery or radiation. The sBLA supporting this indication in combination with carboplatin and paclitaxel for dMMR/MSI-H primary advanced or recurrent endometrial cancer received Breakthrough Therapy designation and Priority Review from the US FDA. Jemperli is also indicated in the US for patients with dMMR recurrent or advanced solid tumours, as determined by a US FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options. The latter indication is approved in the US under accelerated approval based on tumour response rate and durability of response. Continued approval for this indication in solid tumours may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Jemperli was discovered by AnaptysBio, Inc. and licensed to TESARO, Inc., under a collaboration and exclusive license agreement signed in March 2014. Under this agreement, GSK is responsible for the ongoing research, development, commercialisation, and manufacturing of Jemperli, and cobolimab (GSK4069889), a TIM-3 antagonist.

Important Information for Jemperli in the EU
Indication

Jemperli is indicated:

in combination with carboplatin-paclitaxel, for the treatment of adult patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer and who are candidates for systemic therapy;
as monotherapy for treating adult patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing regimen.
Refer to the Jemperli EMA Reference Information for a full list of adverse events and the complete important safety information in the EU.

On June 24, 2024 GSK plc (LSE/NYSE: GSK) reported that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Omjjara (momelotinib) for the treatment of myelofibrosis (Press release, GlaxoSmithKline, JUN 24, 2024, View Source [SID1234644499]). Omjjara is a once-a-day, oral JAK1/JAK2 and activin A receptor type 1 (ACVR1) inhibitor. The approval is based on data from the pivotal phase III MOMENTUM and SIMPLIFY-1 trials.

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This is the fourth major regulatory approval for GSK’s momelotinib in the treatment of myelofibrosis, following approval under the brand name Ojjaara from the US Food and Drug Administration and authorisations under the brand name Omjjara from the European Commission and the Medicines and Healthcare products Regulatory Agency in the UK.

Nina Mojas, Senior Vice President, Oncology Global Product Strategy, GSK, said: "Myelofibrosis has a heavy disease burden, with symptomatic patients experiencing spleen enlargement, fatigue, night sweats and bone pain, along with anaemia which can lead to treatment discontinuation and dependence on regular blood transfusions. With the approval of Omjjara, myelofibrosis patients in Japan will have a new treatment option for this complex blood cancer."

Myelofibrosis is a blood cancer that affects approximately 1 in 500,000 people worldwide, with up to 5,000 patients impacted in Japan.4,5,6 In Japan, about 70% of patients diagnosed with primary myelofibrosis, and about half of those patients diagnosed with secondary myelofibrosis, have moderate to severe anaemia at the time of diagnosis.1,2,3 Nearly all patients are estimated to develop anaemia over the course of the disease.7,8,9,10 Myelofibrosis patients with anaemia require additional supportive care, including transfusions, and more than 30% will discontinue treatment with established therapies due to anaemia.11 Patients who are anaemic and transfusion dependent have a poor prognosis and shortened survival.12,13,14,15,16,17,18,19,20

The approval is based on data from the MOMENTUM and SIMPLIFY-1 pivotal phase III trials. MOMENTUM was designed to evaluate the safety and efficacy of momelotinib versus danazol for the treatment and reduction of key manifestations of myelofibrosis in an anaemic, symptomatic, JAK inhibitor-experienced population. SIMPLIFY-1 was designed to evaluate the efficacy and safety of momelotinib versus ruxolitinib in myelofibrosis patients who had not received a prior JAK inhibitor therapy.

About Omjjara (momelotinib)
Momelotinib has a differentiated mechanism of action, with inhibitory ability along three key signalling pathways: Janus kinase (JAK) 1, JAK2, and activin A receptor, type I (ACVR1).1,21,22,23 Inhibition of JAK1 and JAK2 may improve constitutional symptoms and splenomegaly.1,21,23 Additionally, inhibition of ACVR1 leads to a decrease in circulating hepcidin levels, potentially contributing to anaemia-related benefit.1,21,22,23

In September 2023, the US Food and Drug Administration licensed24 momelotinib under the brand name Ojjaara for the treatment of intermediate or high-risk myelofibrosis, including primary myelofibrosis or secondary myelofibrosis (post-polycythaemia vera and post-essential thrombocythemia), in adults with anaemia.

In January 2024, the European Commission granted marketing authorisation25 for Omjjara for disease-related splenomegaly (enlarged spleen) or symptoms in adult patients with moderate to severe anaemia who have primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythemia myelofibrosis and who are Janus kinase (JAK) inhibitor naïve or have been treated with ruxolitinib. Omjjara was also approved26 by the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom to treat the symptoms experienced by adult myelofibrosis patients who have moderate or severe anaemia.

Please refer to the updated Product Information (PI) for precautions concerning indication and important dosage, administration, and safety information in Japan which will shortly be updated at this link: Japan Pharmaceuticals and Medical Devices Agency.27

About myelofibrosis
Myelofibrosis is a rare blood cancer that disrupts the body’s normal production of blood cells because of dysregulated JAK-signal transducer and activator of transcription protein signalling. The clinical hallmarks of myelofibrosis are splenomegaly (enlarged spleen), severely low blood counts, including anaemia and thrombocytopenia, and debilitating constitutional symptoms, such as fatigue, night sweats and bone pain, attributable to ineffective haematopoiesis and excessive production of proinflammatory cytokines.28,29

About the pivotal clinical trials
MOMENTUM was a phase III, global, multicentre, randomised, double-blind study investigating momelotinib versus danazol in patients (n=195) with myelofibrosis who were symptomatic and anaemic and had been previously treated with a licensed JAK inhibitor. The trial was designed to evaluate the safety and efficacy of momelotinib for treating and reducing key hallmarks of the disease: symptoms, blood transfusions (due to anaemia) and splenomegaly. The MOMENTUM trial met all its primary and key secondary endpoints, demonstrating statistically significant response with respect to constitutional symptoms, splenic reduction and transfusion independence in patients treated with momelotinib versus danazol (Total Symptom Score reduction of 50% or greater: 25% momelotinib, 9% danazol, p=0.0095; reduction of spleen volume by 35% or greater: momelotinib 22%, danazol 3%, p=0.0011; no transfusions and all haemoglobin values ≥8 g/dL in the 12 weeks prior to week 24: momelotinib 30%, danazol 20%).30 The most common non-haematological treatment-emergent adverse events in momelotinib-treated patients over the entire study period as of the data cutoff were diarrhoea (45 [26%] of 171) and asthenia (28 [16%]); the most common grades 3 and 4 treatment-emergent adverse events were thrombocytopenia (33 [19%]) and anaemia (19 [11%]).31 Results from the 24-week randomised treatment period were presented at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and subsequently published in The Lancet,32,33 with 48-week data presented at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in December 2022 and subsequently published in The Lancet Hematology.31,34

SIMPLIFY-1 was a multicentre randomised, double-blind, phase III study that compared the safety and efficacy of momelotinib to ruxolitinib in patients with myelofibrosis who had not received prior treatment with a JAK inhibitor (momelotinib: n=215 and ruxolitinib: n=217). SIMPLIFY-1 met its primary endpoint, demonstrating non-inferiority of momelotinib to ruxolitinib in spleen volume response (reduction by 35% or greater) with a difference of 9% (95% CI 2%-16%), and substantial improvements in transfusion independence rates (66.5% for momelotinib compared to 49.3% for ruxolitinib), a difference of 18% (95% CI 9%-26%).35,36 The most common grade 3 or higher haematologic abnormalities in either group were thrombocytopenia and anaemia. Grade 3 or higher infections occurred in 7% of patients who received momelotinib and 3% of patients who received ruxolitinib.