On October 31, 2023 INmune Bio, Inc. (NASDAQ: INMB) (the "Company"), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, reported an update regarding the company’s patent covering its proprietary cell line, "INB16", as well as the therapeutic composition comprising replication-incompetent INB16 cells known as "INKmune" and methods of treating cancer by administering INKmune, with a goal of achieving in vivo priming of natural killer (NK) cells to enhance the ability of a patient’s own NK-cells to effect cancer surveillance, recognition, and killing (Press release, INmune Bio, OCT 31, 2023, View Source [SID1234636530]).

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In the written opinion for the international patent application titled, "HUMAN T-CELL ACUTE LYMPHOBLASTIC LEUKEMIA CELL LINE & APPLICATIONS FOR TREATING CANCER," an examiner from the International Search Authority at the United States Patent & Trademark Office, authorized by the World Intellectual Property Organization under the Patent Cooperation Treaty, issued a favorable patentability opinion with respect to novelty, inventive step and industrial applicability of all claims and concluding that the application contains patentable subject matter. The application discloses and claims the novel INB16 cell line on deposit with the American Type Culture Collection, as well as compositions comprising replication incompetent INB16 cells ("INKmune") and methods of treating cancer in patients by administering INKmune.

"Patents covering novel cell lines are somewhat rare in practice and form a very small number of total patents issued," said Joshua Schoonover, Esq., in-house General Counsel for the Company. "The company is exploring several potential commercial applications of the INB16 cell line, including uses in cancer research, as well as therapeutic uses, such as applications for treating various cancer indications, or for enhancing other NK cell products to gain advantages, such as improved avidity or memory-like functions."

The Company intends to leverage the favorable written opinion under the patent prosecution highway, a program offered by the USPTO, EPO and other participating patent offices to accelerate examination and ultimately patent issuance for inventions receiving favorable opinions received from certain patent authorities, including WIPO.

INB16 is a tumor cell line which is relatively insensitive to killing by natural killer (NK) cells from healthy donors and from patients. However, it carries molecules on its surface which bind to critical activating ligands on resting NK (rNK) cells and, when an rNK cell binds to INB16 the rNK becomes primed by the activating ligands. One of the key molecules on the INB16 surface is called CD15 and this binds to a ligand on rNK cells called CD2. Virtually all rNK in the blood express CD2. The Company has shown that this CD15-CD2 interaction is critical and has further mapped the intracellular signaling cascade that it activates. During the next 16 hours after INB16 binding, the rNK becomes "primed" to form what is called a "tumor-primed NK cell" – TpNK. These TpNK have the characteristics of memory-like NK cells described by other groups and which are produced in the lab by priming with a cocktail of inflammatory cytokines (IL12/15/18). TpNK are a type of mlNK and can kill tumor cells that are resistant to rNK cell-killing. This means that they can kill a wide range of clinically relevant cancers and leukemias. In addition, the Company’s in vitro data shows that TpNK cells are able to overcome the immunosuppression of hypoxia and regulatory cells in an active Tumor Microenvironment of solid tumors. The Company is extending these findings to show that INKmune-primed NK cells also overcome immunosuppressive cytokines in the TME as a result of the NK differentiation into a memory-like cell.

While INB16 can generate TpNK cells in vitro, it cannot be used to treat NK cells in the blood of patients without being treated to prevent it from further proliferation. To overcome this, the Company uses novel methods to make the INB16 unable to replicate and created a "replication-incompetent cell," which forms a basis of the biologic called "INKmune." The Company has safely treated five patients with hematological cancers and shown that INKmune treatment converts patient’s normal resting NK cells into potent memory-like NK cells much like those that can be produced in vitro. More patients are awaiting trial enrolment. Administration of INKmune may be the only way to create mlNK in vivo because the cytokine cocktail used by others would be too toxic to use as a direct treatment.

The Company opened an IND for a US trial of INKmune in metastatic castration-resistant prostate cancer. The first site will be initiated in the second week of November, meaning that efforts are ahead of schedule for the planned first patient treatment in this quarter. At least one other site is expected to be opened before the end of the year. A clinical batch of INKmune has been manufactured for the first US cohort and is ready to be shipped to a distribution center. Patients at each dose level will receive all three doses of INKmune as an out-patient treatment during the six-month trial. Two markers of INKmune efficacy will be measured – immunologic activation and therapeutic efficacy as a measure tumor response to INKmune therapy, using traditional biomarkers of prostate cancer tumor burden (progression-free survival, changes in blood PSA level, and tumor burden measured by bone and CT scan).

On October 31, 2023 Incyte (Nasdaq:INCY) reported 2023 third quarter financial results, and provides a status update on the Company’s clinical development portfolio (Press release, Incyte, OCT 31, 2023, View Source [SID1234636529]).

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"Our double-digit revenue growth during the quarter was driven by sustained performance of Jakafi (ruxolitinib) and an increasing contribution from Opzelura (ruxolitinib) with continued strong patient demand and enhanced payer coverage," said Hervé Hoppenot, Chief Executive Officer, Incyte. "We made significant progress with our early programs in myeloproliferative neoplasms (MPNs), including mCALR and JAK2V617F, which have the potential to be disease modifying therapies that represent a fundamentally new approach to the way patients with MPNs are treated. Additionally, we recently received positive top line results from the Phase 2 study of povorcitinib in prurigo nodularis (PN) and plans are underway to initiate a Phase 3 study in 2024. With approximately 100,000 treated PN patients in the U.S., povorcitinib has the potential to be an efficacious therapy for those patients who currently have limited treatment options."
Key Company Updates
•In September, Incyte was notified by the Centers for Medicare and Medicaid Services that ruxolitinib phosphate qualified for the Small Biotech Exception.
•Beginning January 1, 2024, Opzelura will be listed as a Preferred Brand on the CVS Caremark and Aetna formularies impacting roughly 30 million commercial lives in the U.S.
Key Product Sales Performance
Jakafi:
Net product revenues for the quarter of $636 million:
▪Net product revenues grew 3% compared with the third quarter of 2022.
▪Channel inventory at the end of the third quarter of 2023 decreased by approximately $14 million versus the second quarter of 2023. Underlying demand in the third quarter of 2023 continued to grow both year-over-year and quarter-over-quarter.

Opzelura:
Net product revenues for the quarter of $92 million:
▪Net product revenues of $92 million grew 141% compared with the third quarter of 2022, driven by growth in patient demand, refills and expansion in payer coverage as the launch in AD and vitiligo continues.
Pipeline Updates
Myeloproliferative Neoplasms (MPNs) and Graft-Versus-Host Disease (GVHD) – key highlights
▪Combination trials of ruxolitinib twice daily (BID) with zilurgisertib (ALK2) and INCB57643 (BET) are ongoing and continue to enroll. Additional data from these studies are anticipated to be shared in the fourth quarter of 2023.
▪The Phase 1 study evaluating INCA033989 (mCALR) is ongoing and enrolling patients.
▪In October, we announced the development of a new program targeting the JAK2V617F mutation, which is present in 55-60% of myelofibrosis (MF) and essential thrombocythemia (ET) patients, and in 95% of polycythemia vera (PV) patients. INCB100658 is a small molecule inhibitor, targeting the JAK2V617F mutation and we expected to file the IND by year-end 2023.
Indication and status
Ruxolitinib XR (QD)
(JAK1/JAK2) Myelofibrosis, polycythemia vera and GVHD
Ruxolitinib + zilurgisertib
(JAK1/JAK2 + ALK2) Myelofibrosis: Phase 2
Ruxolitinib + INCB57643
(JAK1/JAK2 + BET) Myelofibrosis: Phase 2
Ruxolitinib + CK08041
(JAK1/JAK2 + CB-Tregs)
Myelofibrosis: Phase 1 (LIMBER-TREG108)
Axatilimab (anti-CSF-1R)2
Chronic GVHD: Pivotal Phase 2 (third-line plus therapy) (AGAVE-201)
Ruxolitinib + axatilimab2
(JAK1/JAK2 + anti-CSF-1R)
Chronic GVHD: Phase 1/2 in preparation
INCA033989
(mCALR) Myelofibrosis, essential thrombocythemia: Phase 1

1 Development collaboration with Cellenkos, Inc.
2 Clinical development of axatilimab in GVHD conducted in collaboration with Syndax Pharmaceuticals.
Other Hematology/Oncology – key highlights
Oral small molecule PD-L1 program: Combination studies evaluating INCB99280 in combination with axitinib (VEGF) and in combination with ipilimumab (CTLA-4) are enrolling. Two Phase 2 monotherapy studies evaluating INCB99280 in patients with select solid tumors who are checkpoint inhibitor naive and in metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC, are enrolling.
2

Indication and status
Pemigatinib (Pemazyre)
(FGFR1/2/3)
Myeloid/lymphoid neoplasms (MLN): approved in the U.S. and Japan
Cholangiocarcinoma (CCA): Phase 3 (FIGHT-302)
Glioblastoma: Phase 2 (FIGHT-209)
Tafasitamab (Monjuvi/Minjuvi)1
(CD19)
Relapsed or refractory diffuse large B-cell lymphoma (DLBCL): Phase 3 (B-MIND)
First-line DLBCL: Phase 3 (frontMIND)
Relapsed or refractory follicular lymphoma (FL) and relapsed or refractory marginal zone lymphoma (MZL): Phase 3 (inMIND)
Retifanlimab (Zynyz)2
(PD-1)
Merkel cell carcinoma (MCC): approved in the U.S.
Squamous cell anal cancer (SCAC): Phase 3 (POD1UM-303)
Non-small cell lung cancer (NSCLC): Phase 3 (POD1UM-304)
MSI-high endometrial cancer: Phase 2 (POD1UM-101, POD1UM-204)
INCB99280
(Oral PD-L1) Solid tumors (combination): Phase 1
Solid tumors (monotherapy): Phase 2
Cutaneous squamous cell carcinoma (cSCC): Phase 2
INCB99318
(Oral PD-L1) Solid tumors: Phase 1

1 Development of tafasitamab in collaboration with MorphoSys.
2 Retifanlimab licensed from MacroGenics.
3 Clinical trial collaboration and supply agreement with Mirati Therapeutics.
Inflammation and Autoimmunity (IAI) – key highlights
Dermatology
Opzelura
▪New results of a pooled analysis of long-term extension (LTE) data from the pivotal Phase 3 TRuE-V program assessing Opzelura cream 1.5% in patients 12 years of age and older with nonsegmental vitiligo who previously experienced limited or no response to treatment at Week 24 were presented at the European Academy of Dermatology and Venereology (EADV) Congress 2023 as a late-breaking oral presentation. These results showed patients who initially experienced limited or no facial or total body repigmentation at six months achieved improved repigmentation after continued treatment with Opzelura for up to two years.
▪Expanded results from the pivotal Phase 3 TRuE-AD3 study evaluating the safety and efficacy of ruxolitinib cream (Opzelura) in children (age ≥2 to <12 years) with atopic dermatitis (AD), the most common type of eczema, met its primary endpoint and was presented at EADV. Significantly more patients treated with ruxolitinib cream (0.75% and 1.5%) achieved Investigator’s Global Assessment Treatment Success than patients treated with vehicle control (non-medicated cream).
▪Ruxolitinib cream in other indications: three Phase 2 studies in lichen planus, lichen sclerosus and mild to moderate hidradenitis suppurativa (HS) have completed enrollment. Two Phase 3 trials evaluating ruxolitinib cream in prurigo nodularis (PN) are ongoing.
Povorcitinib (INCB54707)
▪Positive 52-week data from a Phase 2b clinical trial evaluating the safety and efficacy of povorcitinib, an investigational oral JAK1 inhibitor, in adult patients with extensive nonsegmental vitiligo were presented at EADV as a late-breaking oral presentation. Results showed that treatment with oral povorcitinib was associated with substantial total body and facial repigmentation across all treatment groups at Week 52 and further reinforces the efficacy profile and potential of povorcitinib as an oral treatment for patients with extensive nonsegmental vitiligo.
▪The Phase 2, randomized, double-blind, placebo-controlled, dose ranging study evaluating the efficacy and safety of povorcitinib in participants with PN met its primary endpoint. A Phase 3 study in PN is being planned.
3

▪Asthma and chronic spontaneous urticaria: Two Phase 2 trials in asthma and chronic spontaneous urticaria are enrolling.
Indication and status
Ruxolitinib cream (Opzelura)1
(JAK1/JAK2)
AD: Phase 3 pediatric study (TRuE-AD3)
Vitiligo: Phase 3 (TRuE-V1, TRuE-V2); approved in the U.S. and Europe
Lichen planus: Phase 2
Lichen sclerosus: Phase 2
Hidradenitis suppurativa: Phase 2
Prurigo nodularis: Phase 3 (TRuE-PN1, TRuE-PN2)
Ruxolitinib cream + UVB
(JAK1/JAK2 + phototherapy) Vitiligo: Phase 2
Povorcitinib
(JAK1) Hidradenitis suppurativa: Phase 2b; Phase 3 (STOP-HS1, STOP-HS2)
Vitiligo: Phase 2; Phase 3 planned
Prurigo nodularis: Phase 2
Asthma: Phase 2
Chronic spontaneous urticaria: Phase 2
INCA034460
(anti-IL-15Rβ) Vitiligo: Phase 1 initiated

1 Novartis’ rights to ruxolitinib outside of the United States under our Collaboration and License Agreement with Novartis do not include topical administration.
Discovery and other early development – key highlights
INCA33890 (TGFβR2xPD-1): A Phase 1 study evaluating INCA33890 in patients with select advanced solid tumors has been initiated.
Modality Candidates
Small molecules INCB123667 (CDK2)
Monoclonal antibodies
INCAGN2385 (LAG-3)1, INCAGN2390 (TIM-3)1
Bi-specific antibodies
INCA32459 (LAG-3xPD-1)2, INCA33890 (TGFβR2xPD-1)2

1 Discovery collaboration with Agenus.
2 Development in collaboration with Merus.
Partnered – key highlights
Jakavi (ruxolitinib)- In August, Novartis announced that Jakavi was approved in Japan for the use in GVHD after hematopoietic stem cell transplant.
Indication and status
Ruxolitinib (Jakavi)1
(JAK1/JAK2)
Acute and chronic GVHD: approved in Europe and Japan
Baricitinib (Olumiant)2
(JAK1/JAK2)
AD: approved in Europe and Japan
Severe alopecia areata (AA): approved in the U.S., Europe and Japan
Capmatinib (Tabrecta)3
(MET)
NSCLC (with MET exon 14 skipping mutations): approved in the U.S., Europe and Japan

1 Ruxolitinib (Jakavi) licensed to Novartis ex-U.S. for use in hematology and oncology excluding topical administration.
2 Baricitinib (Olumiant) licensed to Lilly: approved as Olumiant in multiple territories globally for certain patients with moderate-to-severe rheumatoid arthritis; approved as Olumiant in EU and Japan for certain patients with atopic dermatitis.
3 Capmatinib (Tabrecta) licensed to Novartis.
4

2023 Third Quarter Financial Results
The financial measures presented in this press release for the three and nine months ended September 30, 2023 and 2022 have been prepared by the Company in accordance with U.S. Generally Accepted Accounting Principles ("GAAP"), unless otherwise identified as a Non-GAAP financial measure. Management believes that Non-GAAP information is useful for investors, when considered in conjunction with Incyte’s GAAP disclosures. Management uses such information internally and externally for establishing budgets, operating goals and financial planning purposes. These metrics are also used to manage the Company’s business and monitor performance. The Company adjusts, where appropriate, for expenses in order to reflect the Company’s core operations. The Company believes these adjustments are useful to investors by providing an enhanced understanding of the financial performance of the Company’s core operations. The metrics have been adopted to align the Company with disclosures provided by industry peers.

Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used in conjunction with and to supplement Incyte’s operating results as reported under GAAP. Non-GAAP measures may be defined and calculated differently by other companies in our industry.
As changes in exchange rates are an important factor in understanding period-to-period comparisons, Management believes the presentation of certain revenue results on a constant currency basis in addition to reported results helps improve investors’ ability to understand its operating results and evaluate its performance in comparison to prior periods. Constant currency information compares results between periods as if exchange rates had remained constant period over period. The Company calculates constant currency by calculating current year results using prior year foreign currency exchange rates and generally refers to such amounts calculated on a constant currency basis as excluding the impact of foreign exchange or being on a constant currency basis. These results should be considered in addition to, not as a substitute for, results reported in accordance with GAAP. Results on a constant currency basis, as the Company presents them, may not be comparable to similarly titled measures used by other companies and are not measures of performance presented in accordance with GAAP.

On October 31, 2023 Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, reported that it has received official meeting minutes from the Type A meeting with the United States Food and Drug Administration (FDA) held September 28, 2023 in which the FDA reiterated the need for an additional Phase 3 trial of avasopasem manganese (avasopasem) for radiotherapy-induced SOM (Press release, Galera Therapeutics, OCT 31, 2023, View Source [SID1234636528]). The Company also decided to halt the Phase 2b GRECO-2 trial of rucosopasem manganese (rucosopasem) in patients with locally advanced pancreatic cancer (LAPC) and the Phase 1/2 GRECO-1 trial of rucosopasem in patients with non-small cell lung cancer (NCSLC), following a futility analysis of the GRECO-2 trial. The Company believes this decision will enable the Company to conserve cash while it continues to assess potential strategic alternatives with the goal of maximizing shareholder value.

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In the Type A Meeting minutes, the FDA reiterated that results from an additional Phase 3 trial will be required to support resubmission of the Company’s New Drug Application (NDA) for avasopasem in radiotherapy-induced SOM.

"We are disappointed that the FDA did not find the data from our Phase 2b GT-201 and Phase 3 ROMAN trials sufficient for the approval of the NDA for avasopasem," said Mel Sorensen, M.D., Galera’s President and CEO. "After discussing the data with the FDA, it is clear that their position is another Phase 3 trial is required."

To optimize the Company’s resources, it conducted a futility analysis of the GRECO-2 trial to assess the likelihood of a successful outcome. The analysis indicated that the trial was unlikely to succeed as designed. GRECO-2 is a randomized, double-blind, placebo-controlled Phase 2b trial evaluating rucosopasem or placebo in combination with SBRT in patients with LAPC. Overall survival is the trial’s primary endpoint. The trial was designed to enroll 220 patients with final analysis at 120 events (deaths). The trial has enrolled 177 patients to date, and the futility analysis was conducted based on 35 deaths with a data cutoff of October 9, 2023.

Dr. Sorensen continued, "In light of our current resources and the results of the futility analysis, we have made the difficult decision to discontinue both GRECO trials. We will analyze the data collected to date to determine next steps for the asset, and we thank the patients and providers who participated in both trials."

The Company has engaged Stifel, Nicolaus & Company, Inc. to assist in reviewing strategic alternatives for the Company and its portfolio of dismutase mimetics with the goal of maximizing value for its shareholders. Such alternatives may include a merger, sale, divestiture of assets, licensing, or other strategic transaction. If the Company is unable to undertake any strategic alternative, it may be required to cease operations altogether.

Galera estimates that its balance of cash, cash equivalents and short-term investments as of September 30, 2023 was $28.4 million. This figure is preliminary and is subject to completion of the Company’s financial closing procedures. The Company plans to file its Quarterly Report on Form 10-Q for the quarter ended September 30, 2023 on November 14, 2023.

On October 31, 2023 Evaxion Biotech A/S (NASDAQ: EVAX) ("Evaxion" or the "Company"), a clinical-stage TechBio company specializing in the development of AI-Immunology powered vaccines, reported initial results from the EVX-01 Phase 2 clinical trial, confirming previous successful Phase 1 findings (Press release, Evaxion Biotech, OCT 31, 2023, View Source [SID1234636526]). A comprehensive clinical update will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 38th annual meeting, taking place in San Diego, California, from November 1-5, 2023.

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Key highlights of the initial Phase 2 results for the first five metastatic melanoma patients treated with EVX-01 include:

Phase 2 data confirm the favorable safety profile of EVX-01 observed in the Phase 1 trial
Promising immunological and clinical outcomes align with the Phase 1 outcomes
Upon EVX-01 treatment, a pronounced and ongoing tumor reduction was observed in a patient with progressive disease
Phase 2 data confirms Evaxion’s AI-Immunology platform’s ability to identify therapeutically relevant cancer vaccine targets
Christian Kanstrup, CEO of Evaxion, stated, "We firmly believe that our AI-Immunology platform has the potential to revolutionize the field of oncology and infectious diseases. Today’s update underscores its promise in immuno-oncology, with our EVX-01 vaccine safely eliciting robust immune responses in all patients. Notably, a pronounced tumor reduction in a metastatic patient with initial progressive disease following EVX-01 treatment offers hope for those with life-threatening cancer. We are looking forward to discussing these results with potential partners."

Join us at the SITC (Free SITC Whitepaper) meeting to explore the poster titled "Effects of an AI-generated personalized neopeptide-based immunotherapy, EVX-01, in combination with pembrolizumab in patients with metastatic melanoma. A clinical trial update", presented on Saturday, November 4, between 9 a.m. – 8:30 p.m. PDT.

Additionally, don’t miss an in-depth presentation of Evaxion’s EVX-01 Phase 2 clinical results by joining an online webinar featuring the study’s principal investigator, Professor Adnan Khattak, held on November 8 at 11:30 a.m. EST. To register for the event, please follow this link.

Earlier this year, Evaxion reported a successful Phase 1 clinical trial for EVX-01 in combination with a checkpoint inhibitor. The trial demonstrated a 67% clinical response rate while meeting safety standards and reporting only mild adverse events. Further, high-quality neoantigens predicted by AI-Immunology were associated with longer progression-free survival. To learn more, please read here.

About EVX-01 Phase 2 Clinical Trial

EVX-01 is Evaxion’s lead clinical asset and constitutes a peptide-based personalized cancer vaccine. The Phase 2 clinical study is a self-sponsored open-label, single-arm, multi-center trial carried out in collaboration with Merck Sharp & Dohme LLC, and together with leading principal investigators and research centers from Italy and Australia aims at evaluating the efficacy and safety of EVX-01 vaccination in combination with anti-PD1 treatment (pembrolizumab) in treatment-naive patients with metastatic or unresectable malignant stage III or IV melanoma. More information can be accessed under clinical trial ID NCT05309421.

On October 31, 2023 EORTC reported that Acute myeloid leukaemia (AML) is a blood cancer that predominantly occurs in older patients. Intensive chemotherapy regimens have been used for decades to treat patients regarded as sufficiently fit to tolerate this treatment (Press release, EORTC, OCT 31, 2023, View Source [SID1234636524]). Allogeneic haematopoietic cell transplantation following treatment with chemotherapy drugs can reduce the risk of a relapse, thus offering the primary curative approach. However, many older patients with AML treated with intensive chemotherapy die or cannot undergo allogeneic haematopoietic cell transplantation due to toxicity caused by intensive chemotherapy.

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Hypomethylating agents are drugs that have significantly improved the prognosis of elderly patients regarded as unfit to receive intensive treatment. We hypothesised that replacing this intensive chemotherapy with a hypomethylating agent (decitabine) could improve outcomes of patients 60 years of age or older and fit to receive intensive chemotherapy. To investigate this hypothesis, the collaborative groups EORTC Leukaemia Group, GIMEMA and GMDS-SG joined forces to conduct the EORTC-1301-LG-AML21 phase III clinical trial (NCT02172872) in which we compared a 10-day decitabine monotherapy schedule with intensive chemotherapy in this patient population. The study was led by the EORTC Leukaemia Group and coordinated by Professor Gerwin Huls from University Medical Centre Groningen, Professor Michael Lübbert from the University Medical Centre Freiburg, and Professor Pierre Wijermans from the Haga Teaching Hospital (names of study coordinators provided in alphabetical order). Professor Adriano Venditti from the University of Rome Tor Vergata coordinated the GIMEMA activities.

The results, with 606 patients accrued at 54 centres in 9 European countries, were just published1 in one of the leading medical journals (The Lancet Haematology). They showed a comparable overall survival between the two treatment arms (HR 1.04, 95% CI 0.86-1.26; p-value 0.68). At 4 years, 26% of patients from the decitabine arm and 30% from the intensive chemotherapy arm were estimated to be alive. The proportion of patients who underwent allogeneic haematopoietic cell transplantation as a part of the study protocol was comparable as well (40% for decitabine, 39% for "3+7" at 4 years) and more than half of patients in both treatment arms underwent allogeneic haematopoietic cell transplantation at some timepoint. A notable difference between the treatment arms was observed regarding the incidence of severe adverse events during the treatment with decitabine as compared with intensive chemotherapy. Decitabine treatment showed lower incidences of severe infections (41% vs 53%), oral mucositis (2% vs 10%) and diarrhoea (1% vs 8%).