On March 17, 2026 Senhwa Biosciences, Inc. (TPEx: 6492), a clinical stage company focusing on development of first-in-class therapeutics for oncology, rare diseases, and infectious diseases, reported that its first-in-class investigational drug Pidnarulex (CX-5461) has demonstrated a significant research breakthrough in the field of photodynamic therapy (PDT). The research findings have been selected for presentation at the 2026 Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper)—one of the world’s most influential conferences in oncology research—highlighting the innovation of the mechanism and its promising clinical development potential recognized by the international scientific community.

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In recent years, photodynamic therapy (PDT) has increasingly emerged as a promising cancer treatment strategy attracting strong interest from the global pharmaceutical industry. Several major pharmaceutical companies—including Novartis, AstraZeneca, and Roche—have actively invested in related research, acquisitions, and collaborations, exploring the integration of next-generation photosensitizers with photo-immunotherapy approaches.

The pre-clinical study shows that CX-5461 possesses photosensitizing properties. When exposed to ultraviolet (UV) light, the compound generates reactive oxygen species (ROS), leading to oxidative DNA damage and enhanced cancer cell death through both direct cytotoxicity and immune-mediated mechanisms. Under the same drug concentration conditions, cytotoxicity against cancer cells increased by approximately ten-fold.

Further investigation revealed that CX-5461’s binding to G-quadruplex (G4) DNA structures works synergistically with light-induced ROS generation, significantly enhancing anti-tumor activity and prolonging survival. These findings suggest that, beyond its established anti-cancer mechanisms, CX-5461 also has the potential to be developed as a novel photosensitizer for photodynamic and novel photoimmuno-therapy.

This emerging therapeutic strategy could potentially be applied to superficial tumors, skin cancers, and other localized treatment settings, enabling a cross-indication cancer treatment approach and opening new clinical applications in oncology.

The AACR (Free AACR Whitepaper) Annual Meeting serves as a premier global platform for validating groundbreaking science and presenting first-in-class mechanisms of action. Research presented at AACR (Free AACR Whitepaper) frequently shapes future directions in biomedical innovation and often facilitates strategic collaborations, licensing agreements, and co-development opportunities with global pharmaceutical companies. Selection of this study for presentation further enhances the global visibility of CX-5461 in the field of innovative cancer therapeutics.

The research will be presented during the "Radiation and Photodynamic Therapy Response Modifiers" clinical research session at the AACR (Free AACR Whitepaper) 2026 Annual Meeting. Jason Huang, M.D., Chief Medical Officer of Senhwa Biosciences, and Kai‑Wei Hsueh, Ph.D., Associate Director of Clinical Research, will attend the conference and present the findings.

Photodynamic therapy is a medical technology that combines a photosensitizing agent with specific wavelengths of light to activate the compound and generate singlet oxygen or free radicals, selectively destroying diseased cells or tissues. It is widely considered a minimally invasive treatment modality with relatively low systemic toxicity. PDT has already been applied in a range of diseases, including skin cancers, head and neck cancer, esophageal cancer, lung cancer, bladder cancer, and cervical cancer.

Market research also indicates continued growth in the global photodynamic therapy market. The oncology-focused PDT market was estimated at approximately USD 3.54 billion in 2024 and is projected to reach USD 5.89 billion by 2032, representing a compound annual growth rate (CAGR) of approximately 7–8%. With the increasing demand for precision oncology and minimally invasive therapies, photodynamic therapy is emerging as a key area of interest for global pharmaceutical development.

Senhwa Biosciences stated that the newly identified mechanism and application of CX-5461 in photodynamic therapy further demonstrate the compound’s potential as a multi-platform innovative anti-cancer therapeutic. The company will continue advancing related research and clinical development while actively exploring international partnerships and licensing opportunities to accelerate the global development of next-generation cancer treatments.

(Press release, Senhwa Biosciences, MAR 17, 2026, View Source [SID1234663632])

On March 17, 2026 Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, reported multiple abstracts have been accepted for presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting to be held April 17-22, 2026, in San Diego, CA.

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"Preclinical data accepted for presentation at the AACR (Free AACR Whitepaper) Special Conference in Cancer Research: RAS Oncogenesis and Therapeutics and the AACR (Free AACR Whitepaper) Annual Meeting highlight our highly differentiated investigational asset VS-7375, an oral, KRAS G12D (ON/OFF) inhibitor in clinical development for pancreatic, lung, colorectal and other cancers harboring a G12D mutation, the most prevalent KRAS mutation in human cancers," said Jonathan Pachter, Ph.D., chief scientific officer at Verastem Oncology. "While most agents targeting KRAS G12D-driven cancers bind preferentially only to the "ON" (active) or "OFF" (inactive) state of KRAS, VS-7375 engages both active and inactive states with extremely high affinity and long residence time, which corresponds to superior efficacy across pre-clinical models of G12D mutated cancers."

Late-Breaking Abstracts

Late-breaking abstracts will be available on the AACR (Free AACR Whitepaper) Annual Meeting website on April 17, 2026, 12 p.m. PT.

Session: Late-Breaking Research: Experimental and Molecular Therapeutics 2
Abstract #: LB183 / 5
Title: Strong durable tumor regressions with the KRAS G12D ON/OFF inhibitor VS-7375 in combination with PRMT5 inhibition in MTAP-deleted/KRAS G12D-mutant pancreatic cancer
Date and Time: April 20, 2026, 2 p.m. – 5 p.m. PT

Session: Late-Breaking Research: Experimental and Molecular Therapeutics 2
Abstract #: LB197 / 19
Title: VS-7375, a non-covalent dual ON/OFF KRAS G12D inhibitor, displays superior activity to ON-only KRAS G12D inhibitors in preclinical models of pancreatic cancer
Date and Time: April 20, 2026, 2 p.m. – 5 p.m. PT

Regular Abstracts

The accepted abstracts are available on the AACR (Free AACR Whitepaper) Annual Meeting website: AACR (Free AACR Whitepaper) Annual Meeting 2026

Session: Novel Antitumor Agents 3
Abstract & Poster Details: Abstract/Poster #7100, Poster Section #13, Poster Board #20
Title: VS-7375: An oral, selective KRAS G12D dual ON/OFF inhibitor with potent anti-tumor activity as a single agent and in combination with other agents
Date and Time: April 22, 2026, 9 a.m. – 12 p.m. PT

In the KP4 KRAS G12D pancreatic cancer model, VS-7375 (50 mg/kg twice daily), zoldonrasib (100 mg/kg once daily) and daraxonrasib (25 mg/kg once daily), produced similar initial tumor regression through day nine. By approximately day 20, however, zoldonrasib and daraxonrasib lost anti-tumor activity with tumor outgrowth, (mean tumor volume >850 mm by day 30) whereas VS-7375 maintained sustained tumor regression (mean tumor volume ~80 mm by day 30), consistent with pharmacodynamic analyses showing durable pathway inhibition only with VS-7375. VS-7375 also showed deeper tumor regression compared to these RAS ON-only inhibitors in KRAS G12D-mutated lung and colorectal xenograft models.

Session: Therapies Targeting Metastasis
Abstract & Poster Details: Abstract/Poster #2232, Poster Section #32, Poster Board #7
Title: Investigating the combined inhibition of RAF, MEK, and FAK in melanoma molecular subtypes
Date and Time: April 20, 2026, 9 a.m. – 12 p.m. PT

In mutant BRAF-driven models, the combination of the FAK inhibitor VS-4718 and the RAF/MEK clamp avutometinib, with or without the mutant BRAF inhibitor encorafenib, significantly delayed tumor onset, induced regression of established tumors and brain metastases, and prolonged overall survival.

AACR Special Conference in Cancer Research: RAS Oncogenesis and Therapeutics

At the AACR (Free AACR Whitepaper) Special Conference in Cancer Research: RAS Oncogenesis and Therapeutics held March 5-8, 2026, Dr. Jonathan Pachter, delivered a plenary oral presentation titled, "Anti-tumor efficacy of the selective oral KRAS G12D dual ON/OFF inhibitor VS-7375 as a single agent and in combination with targeted agents." This presentation can be found on the Company’s website on the Resources page.

About VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor

VS-7375 is a potential best-in-class, potent, and selective oral KRAS G12D dual ON/OFF inhibitor. VS-7375 is the lead program from the Verastem Oncology discovery and development collaboration with GenFleet Therapeutics. Verastem initiated VS-7375-101, an international Phase 1/2 clinical trial, in June of 2025 in the U.S., that is evaluating the safety and efficacy of VS-7375 in patients with advanced KRAS G12D mutant solid tumors. In July 2025, U.S. Food and Drug Administration (FDA) granted Fast Track Designation (FTD) to VS-7375 for the first-line treatment of patients with KRAS G12D-mutated locally advanced or metastatic adenocarcinoma of the pancreas (PDAC) and for the treatment of patients with KRAS G12D-mutated locally advanced or metastatic PDAC who have received at least one prior line of standard systemic therapy.

About the GenFleet Therapeutics Collaboration

The collaboration with GenFleet Therapeutics aims to advance three oncology discovery programs related to RAS/MAPK pathway-driven cancers. The collaboration provides Verastem with an exclusive option to obtain a license for each of the three compounds in the collaboration after the successful completion of pre-determined milestones in a Phase 1 trial. Verastem selected VS-7375 (also known as GFH375), an oral KRAS G12D (ON/OFF) inhibitor, as its lead program in December 2023 and the license for VS-7375 that was exercised in January 2025 is the first one from this collaboration. The licenses would give Verastem development and commercialization rights outside the GenFleet markets of mainland China, Hong Kong, Macau, and Taiwan.

(Press release, Verastem, MAR 17, 2026, View Source [SID1234663631])

On March 17, 2026 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal immunotherapies to help patients with cancer, reported an additional 12 months of extended follow-up from its study of aglatimagene plus valacyclovir in combination with continued ICI therapy in patients with advanced NSCLC who had an inadequate response to prior ICI treatment. Among the 46 patients who received two administrations of aglatimagene (per-protocol population), 23 patients (50%) remained alive at 24 months. Additionally, 16 patients (35%) survived beyond 30 months, 12 patients (26%) survived beyond 36 months, 11 patients (24%) survived beyond 40 months, and 6 patients (13%) exceeded 50 months of survival. These outcomes represent an improvement from the prior data cut, in which 39% of the patients in the per-protocol population were alive at 24 months, with 10 patients surviving beyond 30 months, 6 patients each beyond 36 and 40 months, and 2 patients beyond 50 months. The extended follow-up further highlights the durability of anti-tumor immunity observed with aglatimagene-based therapy, and the persistence of a long-term survival tail in this difficult-to-treat population.

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Histologic analysis of available baseline and tumor biopsies demonstrated that among evaluable patients surviving beyond 24 months and with PD-L1 status available, (17/20) 85% had baseline PD-L1 TPS below 50% (a population typically less responsive to ICI). These findings highlight the ability of aglatimagene to convert immunologically "cold," ICI-resistant tumors into immune-active microenvironments.

mOS was 25.4 months among 46 evaluable patients who received two courses of aglatimagene (per-protocol population; cohorts 1 and 2). Among evaluable patients with progressive disease at baseline despite prior ICI therapy (cohort 2, n=41), mOS was 21.5 months, and 25.4 months in patients within cohort 2 with non-squamous histology (n=33). These outcomes compare favorably with historical reference mOS of 9.8–11.8 months reported for patients with progressive disease following ICI treatment receiving standard-of-care docetaxel1,2, representing approximately a two-fold improvement in mOS in this difficult-to-treat population. Aglatimagene maintained its generally favorable tolerability profile throughout the extended follow-up period.

Molecular profiling of paired baseline and post-treatment tumor biopsies revealed that long-term survivors exhibited robust upregulation of genes associated with sustained immune activation and antigen presentation. In particular, enhanced interferon signaling and activation of myeloid and antigen-presenting cell programs were observed, including significant increases in the expression of IFNγ, CSF1, CX3CL1, and IL1β (p = 0.010, 0.026, 0.013, and 0.034, respectively). These findings reflect increased local inflammation and recruitment of immune effector populations within the tumor microenvironment following aglatimagene treatment and may have contributed to the durable anti-tumor immune responses observed in long-term survivors.

"These updated survival data further strengthen our previously reported findings, demonstrating the potential of aglatimagene to meaningfully extend survival for patients with advanced NSCLC who have limited treatment options after failing to respond to, or progressing despite, ICI therapy," said Paul Peter Tak, MD, PhD, FMedSci, President and Chief Executive Officer of Candel Therapeutics. "With its differentiated mechanism of action and favorable safety profile observed to date, aglatimagene represents a novel therapeutic approach for solid tumors, with the potential to improve outcomes beyond current standards of care. These compelling results reinforce our commitment to advancing this program as we continue to develop new treatment options for patients facing this aggressive disease."

"The biomarker data presented here reinforces the multimodal anti-tumor activity of aglatimagene," said Francesca Barone, PhD, Chief Scientific Officer of Candel Therapeutics. "Consistent with its proposed prime-boost mechanism, we observed expansion of T-cell receptor diversity in both tumor tissue and peripheral blood following treatment, reflecting a broadening of the adaptive immune response. Notably, similar TCR repertoire expansion was previously reported in patients with glioblastoma treated with aglatimagene (see link: Neuro Oncol 2025;27:2617-2631), supporting a consistent immunologic signature across tumor types. Together with the observed activation of interferon signaling and antigen-presentation pathways, these findings highlight aglatimagene’s ability to drive both local and systemic anti-tumor immunity."

Based on these findings, together with a strong supporting mechanistic data package, the Company plans to advance this program into a pivotal phase 3 clinical trial in patients with NSCLC with non-squamous histology, with trial initiation expected in the second quarter of 2026. The U.S. Food and Drug Administration (FDA) has previously granted Fast Track designation for aglatimagene plus valacyclovir in combination with ICI therapy for the treatment of patients with stage III/IV NSCLC who are resistant to first-line PD-(L)1 inhibitor therapy and who do not harbor activating molecular driver mutations, or who have progressed on directed molecular therapy.

About aglatimagene besadenovec (CAN-2409)

Aglatimagene, Candel’s most advanced multimodal biological immunotherapy candidate, is an investigational, off-the-shelf, replication-defective adenovirus designed to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to a patient’s tumor. After intratumoral administration, HSV-tk enzyme activity results in conversion of prodrug (valacyclovir) into deoxyribonucleic acid (DNA)-incorporating nucleotide analogs, leading to immunogenic cell death in cells exhibiting DNA damage and proliferating cells, with subsequent release of a variety of tumor (neo)antigens in the tumor microenvironment. At the same time, the adenoviral serotype 5 capsid proteins promote inflammation through the induction of expression of pro-inflammatory cytokines, chemokines, and adhesion molecules. Together, this regimen is designed to induce an individualized and specific CD8+ T cell-mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor activity, based on in situ immunization against a variety of tumor antigens. Aglatimagene has the potential to treat a broad range of solid tumors. Encouraging monotherapy activity as well as combination activity with standard of care radiotherapy, surgery, chemotherapy, and immune checkpoint inhibitors have previously been shown in several preclinical and clinical settings. More than 1,000 patients have been dosed with aglatimagene in clinical trials with a favorable tolerability profile to date, supporting the potential for combination with standard of care, when indicated.

(Press release, Candel Therapeutics, MAR 17, 2026, View Source [SID1234663629])

On March 17, 2026 Knight Therapeutics Inc., (TSX: GUD) ("Knight") a pan-American (ex-USA) specialty pharmaceutical company, reported that its Argentine affiliate, Laboratorio LKM S.A., and its Mexican affiliate, Grupo Biotoscana de Especialidad S.A. de C.V., have submitted a supplemental application to ANMAT, the Argentinian health regulatory agency, and COFEPRIS, the Mexican health regulatory agency, respectively, seeking approval for an additional indication for MINJUVI (tafasitamab), in combination with lenalidomide and rituximab, for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) (Grade 1–3a) after at least one prior line of systemic therapy.

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Knight entered into an exclusive supply and distribution agreement with Incyte (NASDAQ: INCY) in September 2021 for tafasitamab (commercialized as MONJUVI (tafasitamab-cxix) in the United States and MINJUVI ex-USA) across Latin America. Knight has launched MINJUVI in Brazil, Mexico and Argentina for use in combination with lenalidomide, followed by MINJUVI monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), who are not eligible for autologous stem cell transplantation (ASCT). In March 2026, Knight announced the approval and launch of MINJUVI in combination with rituximab and lenalidomide for the treatment of adult patients with relapsed or refractory FL in Brazil.1

"In past two years we have launched MINJUVI for the treatment of diffuse large B-cell lymphoma in Brazil, Mexico, and Argentina. More recently, MINJUVI received regulatory approval for the treatment of refractory follicular lymphoma in Brazil," said Samira Sakhia President and Chief Executive Officer of Knight Therapeutics. "We continue to advance our pipeline with the submissions for MINJUVI in both Argentina and Mexico. More importantly, MINJUVI is more than a single product. With approvals across distinct indications, it effectively represents multiple therapies within one brand, expanding the ways physicians can use MINJUVI to address different patient needs. I am proud of the progress we have made with MINJUVI and look forward to continuing our mission to bring high-quality pharmaceuticals that improve patients’ health in our markets."

About MINJUVI (tafasitamab)

MINJUVI (tafasitamab) is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. Tafasitamab incorporates an XmAb engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP). Incyte licenses exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc.

In the U.S., MONJUVI is approved by the U.S. FDA in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL).

MONJUVI is not approved and is not recommended for the treatment of patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials.

Additionally, MONJUVI received accelerated approval in the United States and Canada in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).

In Europe, MINJUVI (tafasitamab) received conditional Marketing Authorization from the European Medicines Agency in combination with lenalidomide, followed by MINJUVI monotherapy, for the treatment of adult patients with relapsed or refractory DLBCL who are not eligible for ASCT. Additionally, MINJUVI is approved in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) (Grade 1-3a) after at least one line of systemic therapy in Europe.

In Japan, MINJUVI is approved in combination with rituximab and lenalidomide for adult patients with relapsed or refractory follicular lymphoma (2L+ FL).

In Brazil, MINJUVI is approved for use in combination with lenalidomide followed by MINJUVI monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from low grade lymphoma in Brazil, who are not eligible for autologous stem cell transplantation (ASCT) and is also approved in MINJUVI, in combination with rituximab and lenalidomide for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). MINJUVI is not approved and is not recommended for the treatment of patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials.

XmAb is a registered trademark of Xencor, Inc.

MONJUVI and MINJUVI are registered trademarks of Incyte.

About Follicular Lymphoma (FL)

FL is the most common subtype of indolent non-hodgkin lymphoma (NHL).2-4 FL typically presents with generalized painless lymphadenopathy that waxes and wanes. It commonly affects the axillary, cervical, femoral, and inguinal lymph nodes. Rarely, it may appear as an asymptomatic large mediastinal mass. Roughly 20% of FL patients experience B symptoms such as night sweats, fever, and weight loss.5 Although patients usually respond to initial therapy, FL will typically relapse over time and is therefore considered incurable.6,7 Approximately a quarter of FL patients are refractory to first-line immunochemotherapy.8 Additionally, there is a risk of histologic transformation to DLBCL or high-grade B-cell lymphomas, which occurs at an estimated annual rate of 2% to 3% and is generally associated with a poor clinical outcomes.9-12

About inMIND Study

The inMIND study (INCMOR 0208-301) was a Phase 3, randomized, double-blind, placebo-controlled, multicenter study in participants with relapsed/refractory FL or relapsed/refractory marginal zone lymphoma (MZL) who had been previously treated with at least one prior line of systemic therapy, including an anti-CD20 antibody. Patients were randomized to receive either tafasitamab + R2 (n = 273) versus placebo + R2 (n = 275). The estimated median progression free survival (PFS; primary endpoint) was 22.37 months (95% CI: 19.22, NE) in the tafasitamab + R2 group compared with 13.93 months (95% CI: 11.53, 16.39) in the placebo + R2 group, with a HR of 0.434 (95% CI: 0.324, 0.580) and a p < 0.0001. Overall, adding tafasitamab to lenalidomide plus rituximab led to a statistically significant, clinically meaningful improvement in PFS, corresponding to a 57% lower risk of progression, relapse, or death in patients with relapsed/refractory follicular lymphoma.13 The most common adverse reactions (≥ 20%) in patients with relapsed or refractory FL were respiratory tract infections, diarrhea, rash, fatigue, constipation, musculoskeletal pain, and cough. The most common Grade 3 or 4 laboratory abnormalities (≥ 20%) were decreased neutrophils and decreased lymphocytes.

(Press release, Knight Therapeutics, MAR 17, 2026, View Source [SID1234663628])

On March 17, 2026 Knight Therapeutics Inc., (TSX: GUD) ("Knight") a pan-American (ex-USA) specialty pharmaceutical company, reported that its Brazilian affiliate, United Medical Ltda. has received approval from ANVISA, the Brazilian health regulatory agency, for an additional indication for MINJUVI (tafasitamab). The approval follows a supplemental regulatory filing and review by ANVISA under Project Orbis for MINJUVI, in combination with rituximab and lenalidomide for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). 1

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The approval is supported by data from clinical studies evaluating MINJUVI in combination with rituximab and lenalidomide (R2), which demonstrated meaningful response rates and durable disease control in patients with previously treated FL.

"ANVISA’s approval of the new indication for tafasitamab in combination with rituximab and lenalidomide represents an important step in expanding treatment options for patients with relapsed or refractory follicular lymphoma. As a chemotherapy-free option with a favorable risk-benefit profile, this approval broadens therapeutic alternatives for patients across Brazil," said Dr Jorge Vaz Pinto Neto, Hematologist, Member of The Board of Directors of the Brazilian Association of Hematology, Hemotherapy, and Cellular Therapy (ABHH-TC) and Coordinator of the Bone Marrow Transplant Unity at CETTRO Cancer Center/ Oncoclinicas – Brasília.

"This approval of MINJUVI delivers on our promise to bring high quality cancer care to Latin America and provides physicians and patients a new option in the treatment of relapsed or refractory lymphoma," said Samira Sakhia, President and CEO of Knight Therapeutics Inc. "The rapid review and approval under Project Orbis reflect Knight’s strong regulatory capabilities and focused execution for the benefit of Knight and our partners."

Knight entered into an exclusive supply and distribution agreement with Incyte (NASDAQ: INCY) in 2021 for tafasitamab (commercialized as MONJUVI (tafasitamab-cxix) in the United States and MINJUVI ex-USA) across Latin America. Knight has launched MINJUVI in Brazil, Mexico and Argentina for use in combination with lenalidomide followed by MINJUVI monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLCBL arising from low grade lymphoma in Brazil, who are not eligible for autologous stem cell transplantation (ASCT).

About MINJUVI (tafasitamab)

MINJUVI (tafasitamab) is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. Tafasitamab incorporates an XmAb engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP). Incyte licenses exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc.

In the U.S., MONJUVI is approved by the U.S. FDA in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL).

MONJUVI is not approved and is not recommended for the treatment of patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials.

Additionally, MONJUVI received accelerated approval in the United States in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).

In Europe, MINJUVI (tafasitamab) received conditional Marketing Authorization from the European Medicines Agency in combination with lenalidomide, followed by MINJUVI monotherapy, for the treatment of adult patients with relapsed or refractory DLBCL who are not eligible for ASCT. Additionally, MINJUVI is approved in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) (Grade 1-3a) after at least one line of systemic therapy in Europe.

In Japan, MINJUVI is approved in combination with rituximab and lenalidomide for adult patients with relapsed or refractory follicular lymphoma (2L+ FL).

In Brazil, MINJUVI is approved for use in combination with lenalidomide followed by MINJUVI monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLCBL arising from low grade lymphoma in Brazil, who are not eligible for autologous stem cell transplantation (ASCT) and is also approved in MINJUVI, in combination with rituximab and lenalidomide for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). MINJUVI is not approved and is not recommended for the treatment of patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials.

XmAb is a registered trademark of Xencor, Inc.

MONJUVI and MINJUVI are registered trademarks of Incyte.

About Follicular Lymphoma (FL)

FL is the most common subtype of indolent non-hodgkin lymphoma (NHL).2-4 FL typically presents with generalized painless lymphadenopathy that waxes and wanes. It commonly affects the axillary, cervical, femoral, and inguinal lymph nodes. Rarely, it may appear as an asymptomatic large mediastinal mass. Roughly 20% of FL patients experience B symptoms such as night sweats, fever, and weight loss.5 Although patients usually respond to initial therapy, FL will typically relapse over time and is therefore considered incurable.6,7 Approximately a quarter of FL patients are refractory to first-line immunochemotherapy.8 Additionally, there is a risk of histologic transformation to DLBCL or high-grade B-cell lymphomas, which occurs at an estimated annual rate of 2% to 3% and is generally associated with a poor clinical outcomes.9-12

In Brazil, according to the 2023 data from the INCA Registries, the expected incidence/year of NHL (inclusive of all subtypes) was 5.57 per 100, 000 in the general population.13 It is expected that follicular lymphoma constitutes 20% to 25% of adult NHL cases.2-4 Globally it is believed to have an estimated prevalence of 1/3000 thus making it a rare disease by both Global and Brazilian regulatory standards.14

About inMIND Study

The inMIND study (INCMOR 0208-301) was a Phase 3, randomized, double-blind, placebo-controlled, multicenter study in participants with relapsed/refractory FL or relapsed/refractory marginal zone lymphoma (MZL) who had been previously treated with at least one prior line of systemic therapy, including an anti-CD20 antibody. Patients were randomized to receive either tafasitamab + R2 (n = 273) versus placebo + R2 (n = 275). The estimated median progression free survival (PFS; primary endpoint) was 22.37 months (95% CI: 19.22, NE) in the tafasitamab + R2 group compared with 13.93 months (95% CI: 11.53, 16.39) in the placebo + R2 group, with a HR of 0.434 (95% CI: 0.324, 0.580) and a p < 0.0001. Overall, adding tafasitamab to lenalidomide plus rituximab led to a statistically significant, clinically meaningful improvement in PFS, corresponding to a 57% lower risk of progression, relapse, or death in patients with relapsed/refractory follicular lymphoma.15 The most common adverse reactions (≥ 20%) in patients with relapsed or refractory FL were respiratory tract infections, diarrhea, rash, fatigue, constipation, musculoskeletal pain, and cough. The most common Grade 3 or 4 laboratory abnormalities (≥ 20%) were decreased neutrophils and decreased lymphocytes.

(Press release, Knight Therapeutics, MAR 17, 2026, View Source [SID1234663627])