Hengrui Pharma Encounters FDA Regulatory Hurdle for Camrelizumab–Rivoceranib; Kailera Therapeutics Announces Positive Results for HRS-7535/KAI-7535 Across Two Phase 3 Studies; Jemperli Underscores Durable Clinical Complete Responses in dMMR/MSI-H Rectal Cancer; FDA Approves PADCEV-Keytruda Combination for Neoadjuvant and Adjuvant Treatment of Muscle-Invasive Bladder Cancer; Sanofi’s Subcutaneous Sarclisa Escena Gains US Approval

Hengrui Pharma Receives FDA Complete Response Letter for Camrelizumab–Rivoceranib Combination in Advanced Liver Cancer

Hengrui Pharma and Elevar Therapeutics have encountered another setback in their efforts to secure U.S. approval for the combination of camrelizumab and rivoceranib, as the FDA has issued a third Complete Response Letter (CRL) for the regimen in first-line liver cancer. Unlike the previous two rejections, which were linked to manufacturing concerns at Hengrui’s camrelizumab facility, the latest decision stems from deficiencies identified during an FDA inspection of the rivoceranib (apatinib) manufacturing site. Hengrui noted that the same facility successfully cleared a European regulatory inspection in 2025.

Despite the repeated regulatory hurdles, the companies have not abandoned the program. The initial CRL was issued in May 2024, followed by a second rejection in March 2025, after which Elevar resubmitted the application in January 2026. According to Hengrui, the FDA’s latest response does not question the clinical efficacy or safety data supporting the therapy.

The resubmitted application included updated final findings from the Phase III CARES-310 study, demonstrating that the camrelizumab-rivoceranib combination reduced the risk of death by 36% compared with Bayer’s Nexavar in patients receiving first-line treatment for unresectable hepatocellular carcinoma.

The latest setback also reflects the broader challenges many Chinese biopharmaceutical companies have encountered while attempting to introduce PD-1 inhibitors into the U.S. market. Although these therapies have been viewed as an important pathway into the competitive U.S. oncology landscape, manufacturing and regulatory obstacles have repeatedly delayed their progress.

Kailera Therapeutics Reports Positive Topline Results from Two Phase 3 Trials of Oral GLP-1 Receptor Agonist HRS-7535/KAI-7535

Kailera Therapeutics reported encouraging topline results from two Phase III clinical studies evaluating the oral small-molecule GLP-1 receptor agonist HRS-7535 (KAI-7535), originally conducted by Hengrui Pharma in China. The HARBOR-1 trial assessed the therapy in adults with obesity or overweight, while the OUTSTAND-2 study evaluated its efficacy in adults with type 2 diabetes (T2D). Both studies achieved positive topline outcomes, reinforcing the therapeutic potential of the candidate across metabolic disorders. In parallel, Kailera is advancing KAI-7535 through a global Phase II clinical trial in individuals with obesity or overweight. The study began enrollment in April 2026, with topline results anticipated in 2027.

Commenting on the findings, Scott Wasserman, M.D., Chief Medical Officer at Kailera, stated that the Phase III data underscore the growing potential of oral GLP-1 small molecules to deliver meaningful weight reduction while offering greater convenience, scalability, and patient accessibility. He added that the ongoing global Phase II study is designed to further optimize KAI-7535 by evaluating a broader dose range, a lower starting dose, and a more gradual dose-escalation strategy to improve its clinical profile across diverse patient populations. Wasserman also noted that KAI-7535 complements Kailera’s broader pipeline strategy of developing differentiated obesity therapies spanning multiple mechanisms and treatment modalities to address the evolving needs of patients.

Jemperli Maintains Clinical Complete Responses in dMMR/MSI-H Locally Advanced Rectal Cancer

GSK plc announced encouraging interim findings from the registrational Phase II AZUR-1 trial evaluating Jemperli (dostarlimab) in patients with stage II/III mismatch repair-deficient/microsatellite instability-high (dMMR/MSI-H) locally advanced rectal cancer. The single-arm study achieved its primary endpoint, demonstrating a durable and clinically meaningful 12-month clinical complete response (cCR12) rate. If approved, dostarlimab has the potential to become the first immunotherapy capable of eliminating or postponing the need for chemotherapy, radiation therapy, and surgery in a subset of patients with this form of rectal cancer.

Rectal cancer, a subtype of colorectal cancer, affects approximately 730,000 people worldwide each year, with the dMMR/MSI-H subtype accounting for an estimated 5–10% of cases. The current standard treatment generally involves chemotherapy, radiation, and surgery, therapies that, while effective, can significantly affect long-term quality of life through complications such as permanent colostomy, functional impairments, and infertility.

Commenting on the findings, Hesham Abdullah, Senior Vice President and Global Head of Oncology, R&D at GSK, stated that the AZUR-1 data highlight the potential of dostarlimab to redefine the treatment approach for patients with dMMR/MSI-H locally advanced rectal cancer. He noted that conventional therapies often carry substantial treatment-related burdens, whereas the trial results indicate that some patients may avoid these interventions while remaining free of detectable disease.

The interim AZUR-1 findings compare favorably with historical treatment outcomes and further reinforce earlier clinical evidence generated in collaboration with Memorial Sloan Kettering Cancer Center, which first demonstrated that dostarlimab could achieve clinical complete responses in patients with dMMR/MSI-H locally advanced rectal cancer without requiring additional therapies.

The interim safety analysis showed that dostarlimab maintained a safety and tolerability profile consistent with previous studies across multiple solid tumors, with no unexpected safety concerns identified. Dostarlimab has already been granted both Breakthrough Therapy and Fast Track designations by the U.S. Food and Drug Administration (FDA) for this indication. GSK intends to submit the interim AZUR-1 results to regulatory authorities worldwide to support potential regulatory review, with detailed trial findings scheduled for presentation at an upcoming scientific meeting.

U.S. FDA Broadens PADCEV Plus Keytruda Approval for Perioperative Treatment of Muscle-Invasive Bladder Cancer

Pfizer Inc. has received approval from the U.S. Food and Drug Administration (FDA) for the use of PADCEV® (enfortumab vedotin-ejfv), a Nectin-4-targeted antibody-drug conjugate, in combination with Keytruda® (pembrolizumab) or Keytruda QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) as both neoadjuvant and adjuvant therapy for adults with muscle-invasive bladder cancer (MIBC), irrespective of their eligibility for cisplatin treatment. With this decision, the combination becomes the first FDA-approved platinum-free perioperative regimen for patients with MIBC across all cisplatin eligibility groups.

The expanded indication is supported by findings from the pivotal Phase III EV-304 (KEYNOTE-B15) trial, which were presented at the 2026 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU). The latest approval broadens the regimen’s earlier U.S. FDA authorization granted in November 2025, when it was approved for cisplatin-ineligible adults with MIBC based on data from the Phase III EV-303 (KEYNOTE-905) study, with results later published in the New England Journal of Medicine.

Commenting on the approval, Christopher Hoimes, DO, Director of the Bladder Cancer Program and Center for Cancer Immunotherapy at Duke Cancer Institute and a principal investigator of the EV-304 study, emphasized the importance of a perioperative treatment strategy for muscle-invasive bladder cancer. He noted that administering therapy before surgery can reduce tumor burden and eliminate microscopic disease at an early stage, while postoperative treatment helps eradicate residual cancer cells that remain undetectable after surgery. According to Hoimes, the EV-304 results demonstrate that combining PADCEV with pembrolizumab across both treatment phases, without relying on platinum-based chemotherapy, can significantly lower the likelihood of disease recurrence while improving overall survival, potentially establishing a new treatment benchmark for patients with MIBC.

In the Phase III EV-304 study, participants were randomly assigned to receive either perioperative PADCEV plus pembrolizumab in combination with surgery or the conventional approach of neoadjuvant chemotherapy followed by surgery. Patients in the investigational arm received a planned course consisting of nine cycles of PADCEV and seventeen cycles of pembrolizumab administered before and after surgical intervention.

Sanofi Wins US Approval for Subcutaneous Sarclisa Escena

The US Food and Drug Administration (FDA) has granted approval to the subcutaneous (SC) formulation of Sarclisa (isatuximab-irfc), marketed as Sarclisa Escena, for use in combination with standard-of-care regimens across all currently approved indications of the intravenous (IV) formulation in patients with multiple myeloma (MM). This approval makes Sarclisa Escena the first oncology therapy that can be administered either through an on-body injector (OBI) or via manual subcutaneous injection.

The FDA’s decision was supported by findings from several clinical studies, including the pivotal Phase III IRAKLIA non-inferiority trial. Results demonstrated that subcutaneous Sarclisa Escena delivered using an OBI achieved efficacy, pharmacokinetic exposure, and safety comparable to IV infusion while significantly reducing administration time and lowering the incidence of infusion-related reactions.

The clinical program utilized Enable Injections’ hands-free CirCLIQ on-body injector, developed on the enFuse® platform, to administer Sarclisa Escena. The automated device delivers high-volume subcutaneous therapies with a single-button activation and incorporates a retractable 30-gauge needle that is both shorter and thinner than conventional needles used for large-volume injections. The approval of Sarclisa Escena alongside the CirCLIQ OBI has the potential to improve the treatment experience for patients with multiple myeloma by simplifying drug delivery.

Beyond enhancing patient convenience, the hands-free injector may also improve clinical workflow by reducing the physical demands associated with drug administration, allowing healthcare providers greater flexibility for patient monitoring and interaction during treatment.

The Phase III IRAKLIA study, the first multiple myeloma trial to evaluate an OBI, showed that Sarclisa SC combined with pomalidomide and dexamethasone (Pd) achieved an objective response rate (ORR) of 71.1% (187/263), compared with 70.5% (189/268) for the IV formulation plus Pd in adults with relapsed or refractory multiple myeloma (R/R MM) who had received at least one prior line of therapy. These findings met the predefined criteria for non-inferiority (relative risk: 1.008; 95% CI: 0.903–1.126).

The safety profile of subcutaneous Sarclisa in combination with Pd was generally consistent with that of the IV formulation. Systemic administration-related reactions occurred in only 1.5% of patients receiving the SC regimen, compared with 25% among those treated intravenously. No new safety signals emerged, apart from injection-site reactions, which were reported in just 0.4% of OBI administrations (19 of 5,145 injections). Nearly all injection-site reactions were mild (Grade 1), with only a single Grade 2 event documented.

The most frequently reported adverse events (≥20%) included upper respiratory tract infection, fatigue, pneumonia, musculoskeletal pain, and diarrhea. Common laboratory abnormalities (≥40%) consisted of reduced leukocyte, neutrophil, lymphocyte, platelet, and hemoglobin levels.

In the United States, Sarclisa is approved for three multiple myeloma indications. These include use in combination with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma (NDMM) patients who are ineligible for autologous stem cell transplantation. For relapsed or refractory disease, it is approved in combination with pomalidomide and dexamethasone for patients who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor, and whose disease has progressed following their most recent treatment. Sarclisa is also authorized for use with carfilzomib and dexamethasone in patients who have received one to three prior lines of therapy.