Rallybio Corporation and Candid Therapeutics Announce Merger Agreement

On March 2, 2026 Rallybio Corporation (Nasdaq: RLYB) ("Rallybio") and Candid Therapeutics, Inc. ("Candid"), a global clinical-stage biotechnology company advancing a leading portfolio of T-cell engager ("TCE") therapeutics for autoimmune diseases, reported that they have entered into a definitive agreement pursuant to which Rallybio will acquire Candid through a merger transaction (the "Merger"). Upon completion of the Merger, the combined company expects to operate under the name Candid Therapeutics, Inc. and trade on Nasdaq under the ticker symbol "CDRX".

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In connection with the Merger, Candid entered into subscription agreements for a concurrent oversubscribed and upsized private financing of over $505 million in gross proceeds (the "Financing" and, together with the Merger, the "Transaction") with a syndicate of leading healthcare institutional investors and mutual funds, including Venrock Healthcare Capital Partners, RA Capital Management, Janus Henderson Investors, accounts advised by T. Rowe Price Associates, Inc., venBio Partners, Viking Global Investors, Cormorant Asset Management, Foresite Capital, Soleus Capital, TCGX, Vivo Capital, a life sciences focused institutional investor, several additional mutual funds and other institutional investors. The combined company’s cash balance at closing is expected to fund operations through 2030, supporting the advancement of Candid’s diversified pipeline of TCE programs through multiple clinical milestones, including the initiation and clinical readouts of Phase 2 studies for cizutamig, a B-cell maturation antigen ("BCMA") targeting TCE, in myasthenia gravis and interstitial lung disease ("ILD") secondary to rheumatological diseases.

The Transaction has been unanimously approved by the boards of directors of both companies and is expected to close in mid-2026, subject to certain closing conditions, including the approval by the stockholders of each company, the effectiveness of a registration statement to be filed with the Securities and Exchange Commission (the "SEC") to register the shares of Rallybio common stock to be issued in connection with the Transaction, the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and the satisfaction of other customary closing conditions. Following closing, pre-Transaction Rallybio equityholders are expected to own approximately 3.65% of the combined company, and pre-Transaction Candid equityholders (inclusive of investors participating in the Financing) are expected to own approximately 96.35% of the combined company, calculated on a treasury stock method basis and assuming Rallybio has net cash at closing of $37.5 million. In addition, pre-closing Rallybio stockholders will receive contingent value rights ("CVRs") entitling them to a portion of certain cash proceeds received by the combined company from its previously announced sale of interests in REV102 and potential disposition of Rallybio’s other legacy assets.

Transaction Highlights

One of the most advanced and diversified TCE pipelines in autoimmune disease, providing significant optionality: Candid has built a leading portfolio of TCE therapeutics for autoimmune disease spanning a wide spectrum of B-cell and plasma cell targets with ongoing clinical studies in over 10 indications:
Cizutamig, a BCMA TCE: Cizutamig has the potential to be the first- and best-in-class BCMA TCE for autoimmune disease, with 87 total patients dosed including 47 autoimmune patients across multiple indications. Cizutamig has demonstrated favorable tolerability with low rates of mild cytokine release syndrome ("CRS"). Emerging clinical data suggest deeper therapeutic activity with less frequent dosing than the anti-FcRn drug class. Global Phase 2 studies in myasthenia gravis and ILD are planned to initiate in 2026.
Potentially best-in-class profile TCEs against CD19 and/or CD20: CND261, a CD20 TCE, has been dosed in over 100 patients across oncology and autoimmune indications, with low rates of CRS and early evidence of deep tissue B-cell depletion. CND319, a dual targeting CD19 and CD20 TCE, has demonstrated a promising therapeutic index profile in non-human primate studies, with first-in-human studies planned for mid-2026.
Additional preclinical programs, including a dual targeting BCMA and CD19 TCE, are also part of the pipeline.
Well-capitalized to execute: Pro-forma cash of approximately $700 million at closing is expected to provide the combined company with a strong financial foundation to advance its pipeline through multiple value-creating milestones.
Experienced leadership team: The combined company will be led by Dr. Ken Song, Chairman, President and CEO of Candid, with a management team that brings deep expertise in autoimmune drug development, TCE biology, and global clinical operations.
Dr. Ken Song, M.D., Chairman, President and Chief Executive Officer of Candid Therapeutics, said: "This transaction marks an exciting moment for Candid as we lead the development of TCEs for patients with autoimmune diseases. By combining with Rallybio and securing over $505 million in new financing from a distinguished group of healthcare investors, we have the resources to advance what we view as a transformative therapeutic modality. With Phase 2 studies planned for cizutamig in 2026 and a rich pipeline of next-generation TCE programs, we will continue to push forward this new drug class."

Dr. Stephen Uden, M.D., Co-Founder and Chief Executive Officer of Rallybio, said: "We are pleased to announce this transaction, which we believe represents a compelling opportunity for Rallybio stockholders to participate in the future value creation of a well-capitalized, clinical-stage company with a differentiated and broad portfolio of TCE drug candidates. Candid’s clinical data in myasthenia gravis and across its autoimmune pipeline, combined with the strong endorsement of leading healthcare investors further substantiates the merit of this transaction."

About the Proposed Transactions

Under the terms of the merger agreement, Rallybio will acquire Candid pursuant to the Merger. At closing, Candid stockholders will receive newly issued shares of Rallybio common stock, with the exchange ratio to be determined based on the relative valuations of the two companies at closing. Immediately following closing, the combined company will change its name to Candid Therapeutics, Inc. and trade on Nasdaq under the ticker symbol "CDRX".

In connection with the Transaction, a syndicate of leading healthcare institutional investors and mutual funds has committed to invest over $505 million in a concurrent private financing in Candid. The Financing is expected to close immediately prior to the Merger. In connection with the Transaction certain stockholders of Candid and Rallybio have executed support agreements, pursuant to which they have agreed to vote all their shares of capital stock in favor of the Transaction.

Wedbush Securities Inc. is serving as financial advisor and Cooley LLP is serving as legal counsel to Candid. Evercore is serving as lead financial advisor, Citizens Capital Markets & Advisory is serving as co-financial advisor, and Ropes & Gray LLP is serving as legal counsel to Rallybio. Jefferies, BofA Securities, TD Cowen and Cantor Fitzgerald are serving as placement agents for the concurrent private financing. Latham & Watkins LLP is serving as legal counsel to the placement agents.

Conference Call Information

Rallybio and Candid will host a joint conference call and webcast on March 2, 2026 at 8:30 AM ET. Please access the presentation by clicking on the following link: View Source

(Press release, Candid Therapeutics, MAR 2, 2026, View Source [SID1234663196])

Jaypirca® (Pirtobrutinib) Approved in China for the Treatment of Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

On March 1, 2026 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures, and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metabolic, ophthalmologic, and other major diseases, reported the non-covalent (reversible) Bruton’s tyrosine kinase (BTK) inhibitor, Jaypirca (pirtobrutinib), has received approval by the National Medical Products Administration (NMPA) in China for a new indication for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) after at least one line of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor.

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Pirtobrutinib is a highly selective kinase inhibitor that utilizes a novel non-covalent binding mechanism to extend the benefit of targeting the BTK pathway in CLL/SLL patients previously treated with a covalent BTK inhibitor (ibrutinib, acalabrutinib, or zanubrutinib).[1],[2] Pirtobrutinib received approval from the U.S. FDA in January 2023 as a non‑covalent (reversible) BTK inhibitor. In October 2024, pirtobrutinib was approved in China as a monotherapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have previously received at least two prior systemic therapies, including a Bruton’s tyrosine kinase (BTK) inhibitor.

The approval of this new indication is based on results from the international, multicenter, randomized, Phase 3 BRUIN CLL‑321 study. BRUIN CLL‑321 is the world’s first randomized Phase 3 trial conducted in patients with CLL/SLL who had previously been treated with a covalent BTK inhibitor (cBTKi). The study enrolled a total of 238 patients and evaluated the efficacy and safety of pirtobrutinib monotherapy versus investigator’s choice of IdelaR (idelalisib plus rituximab) or BR (bendamustine plus rituximab). The results demonstrated that pirtobrutinib significantly prolonged median progression‑free survival (PFS) compared with the investigator’s choice regimen (14.0 months vs 8.7 months; hazard ratio [HR] = 0.54). In addition, the discontinuation rate due to treatment‑related adverse events was lower with pirtobrutinib (5.2% vs 21.1%), further supporting its efficacy and tolerability advantages in patients previously treated with a covalent BTK inhibitor.[3]

Professor Lu-Gui Qiu, Principal Investigator of the BRUIN CLL‑321 study in China, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences, stated, "BTK inhibitors have become the preferred first‑ or second‑line treatment for patients with CLL/SLL, yet some patients still experience disease progression and have a poor prognosis. Studies have shown that the median overall survival for patients after discontinuing a covalent BTK inhibitor is only about 22.7 months.[4] Therefore, there is an urgent clinical need for new treatment. As a next‑generation, non‑covalent and reversible BTK inhibitor, pirtobrutinib represents an important advancement for patients with relapsed or refractory CLL. The BRUIN CLL‑321 study demonstrated its therapeutic potential in CLL/SLL. We believe it will offer an important treatment option for patients with CLL/SLL in China and help meet the needs of long‑term disease management in the future."

Dr. Li Wang, Lilly Corporate Senior Vice President, Head of Lilly China Drug Development & Medical Affairs Center, states, "The approval of pirtobrutinib for the CLL/SLL indication in China marks an important milestone in the treatment journey for Chinese CLL/SLL patients. It means that patients who continue to experience disease progression after covalent BTK inhibitor therapy can now gain timely access to this globally innovative treatment option. Supported by the efficacy and safety demonstrated in the BRUIN CLL‑321 study, we are pleased to offer a new therapeutic choice for CLL/SLL patient population with significant unmet medical needs in China. Looking ahead, Lilly will remain committed to accelerating the introduction of cutting‑edge therapies to help patients with hematologic malignancies in China achieve longer and better quality of survival. This is our enduring commitment to patients in China."

Dr. Hui Zhou, Chief R&D Officer of Oncology in Innovent, stated, "Jaypirca (pirtobrutinib) is a next-generation, non-covalent (reversible) BTK inhibitor. It offers a novel treatment option for patients who have previously received covalent BTK inhibitor therapy. The approval in China for CLL/SLL represents a significant breakthrough in this field, which ensures that CLL/SLL patients in China have timely access to this global therapeutic innovation. We will fully leverage Innovent’s leading brand presence and commercialization capabilities in oncology, to accelerate the accessibility of this innovative therapy, thereby benefiting more cancer patients in need."

About BRUIN CLL-321
BRUIN CLL-321 is a Phase 3, randomized, open-label study of Jaypirca versus investigator’s choice of idelalisib plus rituximab (IdelaR) or bendamustine plus rituximab (BR) in covalent Bruton tyrosine kinase (BTK) inhibitor pre-treated patients with relapsed and refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The trial enrolled 238 patients, who were randomized 1:1 to receive Jaypirca (200 mg orally, once daily) or investigator’s choice of either IdelaR or BR per labeled doses. This trial’s primary endpoint is progression-free survival (PFS) per 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria, as assessed by blinded independent review committee (IRC). Secondary endpoints include PFS, as assessed by investigator; overall response rate (ORR) and duration of response (DoR); event-free survival; overall survival (OS) and time to next treatment (TTNT); safety and tolerability; and patient-reported outcomes (PRO).

About Jaypirca (pirtobrutinib)
Jaypirca (pirtobrutinib, formerly known as LOXO-305) (pronounced jay-pihr-kaa) is a highly selective (300 times more selective for BTK versus 98% of other kinases tested in preclinical studies), non-covalent (reversible) inhibitor of the enzyme BTK.[2] BTK is a validated molecular target found across numerous B-cell leukemias and lymphomas including mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL).[5],[6]

In China, pirtobrutinib was developed by Eli Lilly and Company and is commercialized in mainland China by Innovent Biologics.

About Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) are forms of slow-growing non-Hodgkin lymphoma that develop from white blood cells known as lymphocytes.[7] In China, chronic lymphocytic leukemia (CLL) represents approximately 6%–7% of non-Hodgkin lymphoma cases.[8] SLL is identical to CLL from a pathologic and immunophenotypic standpoint, with the main difference between them being the location of the cancer cells. In CLL, the cancer cells are present in the blood, and in SLL, the cancer cells are found in the lymph nodes.

(Press release, Innovent Biologics, MAR 1, 2026, View Source [SID1234663146])

XPOVIO® Receives Reimbursement Approval in South Korea for a Second Multiple Myeloma Indication

On March 1, 2026 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK) , a leading innovative, commercial-stage global biotech company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for autoimmune disease, solid tumors and hematological malignancies indications, reported that South Korea’s National Health Insurance Service (NHIS) has approved the reimbursement of XPOVIO (selinexor) in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma (MM) after one prior therapy. The reimbursement has taken effect on March 1, 2026. This marks the second XPOVIO indication to be approved for reimbursement in South Korea.

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As Antengene continues to expand its footprint across the Asia Pacific region, the Company remains committed to improving patient access to its innovative therapies. To date, XPOVIO has been approved in South Korea for three indications in MM and diffuse large B-cell lymphoma (DLBCL), both major hematological malignancies. Two of these indications have been approved for reimbursement, including XPOVIO in combination with dexamethasone for the treatment of adult patients with relapsed or refractory MM (R/R MM) who have received at least four prior therapies, as well as the newly reimbursed indication. With expanded reimbursement coverage, XPOVIO is expected to benefit a broader patient population and further contribute to the management of hematological malignancies in South Korea.

With a novel mechanism of action, XPOVIO is the world’s first approved orally-available, selective XPO1 inhibitor. XPOVIO has already been approved in ten countries and regions in APAC, and has been included in the national insurance schemes in five of these markets (the mainland of China, Taiwan market, Australia, Singapore and South Korea). Moving forward, Antengene will continue to pursue broader access for XPOVIO across APAC markets.

(Press release, Antengene, MAR 1, 2026, View Source [SID1234663147])

InnoCare’s next-generation TRKi Zurletrectinib Receives Priority Review for the Treatment of Pediatric Patients with Solid Tumors in China

On March 1, 2026 InnoCare Pharma (HKEX: 09969), a leading biopharmaceutical company for the treatment of cancer and autoimmune diseases, reported that its next generation TRK inhibitor zurletrectinib (ICP-723) has been granted priority review by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA), for the treatment of pediatric patients (aged 2 to 12) with solid tumors harboring NTRK gene fusions. Priority review is one of the key policies introduced by the CDE to accelerate drug approval.

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Zurletrectinib has also been included in the "SPARK Program" by the CDE, a pilot initiative to encourage the development of pediatric anti-tumor drugs.

In December 2025, zurletrectinib received approval for the treatment of adult and adolescent patients (aged 12 years and older) with solid tumors harboring NTRK gene fusions in China. In the registrational clinical trial for patients with NTRK fusion-positive solid tumors, zurletrectinib demonstrated outstanding efficacy and a favorable safety profile. The study results showed an objective response rate (ORR) of 89.1%, a disease control rate (DCR) of 96.4%, and 24-month progression-free survival (PFS) and overall survival (OS) rates of 77.4% and 90.8% respectively.

In October 2025, the data from the Phase I/II clinical trial of zurletrectinib for the treatment of pediatric and adolescent patients with advanced solid tumors were released at the Congress of International Society of Pediatric Oncology (SIOP) 2025 as an oral presentation. Zurletrectinib demonstrated a well-tolerated safety profile and promising antitumor activity in pediatric/adolescent patients with NTRK/ROS1-altered solid tumors. The results highlight zurletrectinib’s strong potential as a next-generation therapy for NTRK/ROS1-driven malignancies, with the ability to overcome resistance to first-generation TRK inhibitors.

NTRK fusion genes occur in various types of adult and pediatric tumors. In some rare tumors, such as salivary gland carcinoma, secretory breast cancer, and infantile fibrosarcoma, the incidence of NTRK gene fusion exceeds 90%1. It is estimated that there are about 6,500 new cases of NTRK fusion-positive solid tumors diagnosed in China each year. There are significant unmet clinical needs in this area due to the lack of effective treatment options.

(Press release, InnoCare Pharma, MAR 1, 2026, View Source [SID1234663148])

WELIREG® (belzutifan) Plus LENVIMA® (lenvatinib) Reduced the Risk of Disease Progression or Death by 30% Compared to Cabozantinib in Certain Previously Treated Patients With Advanced Renal Cell Carcinoma (RCC)

On February 28, 2026 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Eisai reported the first presentation of results from the Phase 3 LITESPARK-011 trial evaluating the dual oral regimen of WELIREG (belzutifan), Merck’s first-in-class oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, plus LENVIMA (lenvatinib), an orally available multiple receptor tyrosine kinase inhibitor (TKI) discovered by Eisai, for the treatment of patients with advanced renal cell carcinoma (RCC) whose disease progressed on or after treatment with anti-programmed death receptor-1 (PD-1)/programmed death-ligand 1 (PD-L1) therapy. These data are being presented as a late-breaking oral abstract at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary (GU) Cancers Symposium (abstract #LBA417) and are included in the official ASCO (Free ASCO Whitepaper) GU Press Program.

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At a pre-specified interim analysis with a median follow-up of 29.0 months (range, 19.3-49.2), WELIREG plus LENVIMA demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS), reducing the risk of disease progression or death by 30% (HR=0.70 [95% CI, 0.59-0.84]; p=0.00007) compared to cabozantinib. For WELIREG plus LENVIMA, the median PFS was 14.8 months (95% CI, 11.2-16.6) versus 10.7 months (95% CI, 9.2-11.1) for cabozantinib. A trend toward improvement in overall survival (OS), the trial’s other primary endpoint, was also observed for WELIREG plus LENVIMA (HR=0.85 [95% CI, 0.68-1.05]; p=0.06075). The median OS was 34.9 months (95% CI, 27.5-NR) for WELIREG plus LENVIMA versus 27.6 months (95% CI, 24.0-31.4) for cabozantinib. The trial is continuing, and OS will be evaluated at a subsequent analysis per the clinical trial protocol.

Based on data from the LITESPARK-011 trial, the U.S. Food and Drug Administration (FDA) has accepted two supplemental New Drug Applications (sNDA) for review seeking approval for WELIREG plus LENVIMA for the treatment of adult patients with advanced RCC with a clear cell component following a PD-1 or PD-L1 inhibitor. The FDA set a Prescription Drug User Fee Act (PDUFA), or target action date, of October 4, 2026 for both the WELIREG and LENVIMA sNDAs. Merck and Eisai will also discuss these data with regulatory authorities worldwide to support potential submissions outside the United States.

"Choosing the right treatment for patients with advanced renal cell carcinoma after immunotherapy has been an ongoing challenge, and treatment options in this setting had not previously been evaluated against a current standard of care tyrosine kinase inhibitor in a Phase 3 trial," said Dr. Robert Motzer, Principal Investigator and Genitourinary Medical Oncologist, Memorial Sloan Kettering Cancer Center. "The LITESPARK-011 study demonstrated a 30% reduction in the risk of disease progression or death with belzutifan plus lenvatinib compared to cabozantinib, and 52.6% of patients experienced a response to treatment. These findings mark a critical step forward for these patients."

"The LITESPARK-011 trial highlights the potential of this first-of-its-kind combination regimen to deliver a meaningful benefit for patients with advanced renal cell carcinoma whose disease progresses after PD-1/L1 therapy," said Dr. M. Catherine Pietanza, Vice President, Global Clinical Development, Merck Research Laboratories. "These WELIREG plus LENVIMA data demonstrate important progress for patients with advanced renal cell carcinoma and reinforce our commitment to improving the lives of patients through innovative treatment strategies."

"The LITESPARK-011 results reinforce LENVIMA’s established role in renal cell carcinoma and highlight the potential of this novel combination to address an area of significant unmet need," said Dr. Corina Dutcus, Senior Vice President, Oncology Global Clinical Development Lead at Eisai. "The acceptance of this regulatory filing is an important milestone, and we remain committed to working toward approval to bring this option to patients as soon as possible. We are grateful to the patients, their families, and the investigators, whose dedication made this research possible."

Additional findings

Data for objective response rate (ORR) and duration of response (DOR), two key secondary endpoints, were also reported. At the first interim analysis with a median follow-up of 19.6 months (range, 9.9-39.8), WELIREG plus LENVIMA met ORR, demonstrating a statistically significant improvement compared to cabozantinib. A confirmed ORR of 52.6% (95% CI, 47.3-57.7) was observed for WELIREG plus LENVIMA versus 39.6% (95% CI, 34.6-44.8) for cabozantinib. At the second interim analysis with a median follow-up of 29.0 months, the median DOR was 23.0 months (95% CI, 2.0-44.3+) for WELIREG plus LENVIMA versus 12.3 months (95% CI, 1.8+-35.9+) for cabozantinib.

WELIREG plus LENVIMA was administered to 370 patients and cabozantinib was administered to 371 patients. Grade ≥3 treatment-related adverse events (TRAEs) occurred in 71.6% of patients receiving WELIREG plus LENVIMA versus 65.8% of patients receiving cabozantinib. Adverse events led to the discontinuation of 11.1% of patients receiving WELIREG plus LENVIMA versus 11.3% of patients receiving cabozantinib, respectively. Serious adverse events were observed in 51.6% of patients receiving WELIREG plus LENVIMA versus 43.9% of patients receiving cabozantinib, and AEs led to death in 5.4% of patients (two were treatment-related: thrombotic microangiopathy [n=1] and pneumonitis [n=1]) versus 3.2% (one was treatment-related: hemoptysis [n=1]) of patients, respectively.

LITESPARK-011 is part of a comprehensive late-stage clinical development program for WELIREG comprised of several Phase 2 and Phase 3 trials in pheochromocytoma and paraganglioma, von Hippel-Lindau disease-associated neoplasms and RCC.

The Phase 3 LITESPARK-012 trial is evaluating the addition of WELIREG to KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, plus LENVIMA in the first-line advanced RCC disease setting.

WELIREG is approved in the U.S., European Union (EU), Japan and other countries for the treatment of adult patients with advanced clear cell RCC following a PD-1/PD-L1 inhibitor and 1-2 VEGF-TKIs based on results from the Phase 3 LITESPARK-005 trial.

KEYTRUDA plus LENVIMA is approved in the U.S., the EU, Japan and other countries for the treatment of advanced RCC. Lenvatinib is approved as KISPLYX for advanced RCC in the EU.

LENVIMA in combination with everolimus is approved in the U.S., EU and other regions for the treatment of adult patients with advanced RCC following one prior anti-angiogenic therapy.

Dr. Motzer has provided consulting and advisory services for Merck and Eisai.

About LITESPARK-011

LITESPARK-011 is a randomized, open-label Phase 3 trial (ClinicalTrials.gov, NCT04586231) evaluating WELIREG in combination with LENVIMA compared to cabozantinib for the treatment of patients with advanced clear cell RCC that has progressed on or after anti-PD-1/L1 therapy. The dual primary endpoints are PFS per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as assessed by blinded independent central review (BICR) and OS. Key secondary endpoints include ORR per RECIST v1.1 as assessed by BICR, DOR per RECIST v1.1 as assessed by BICR, and safety. The trial enrolled 747 patients who were randomized to receive WELIREG (120 mg orally once daily) plus LENVIMA (20 mg orally once daily) or cabozantinib (60 mg orally once daily).

About renal cell carcinoma

Renal cell carcinoma is the most common type of kidney cancer, with about nine out of 10 kidney cancer diagnoses being RCC. In 2022, there were about 435,000 new cases of kidney cancer and approximately 156,000 deaths from the disease worldwide. RCC is about twice as common in men as in women. Most cases of RCC are discovered incidentally during imaging tests for other abdominal diseases. Approximately 30% of patients with kidney cancer are diagnosed at an advanced stage.

(Press release, Merck & Co, FEB 28, 2026, View Source [SID1234663143])