Group 1: Amgen (AMGN.US) - Amgen's Imdelltra shows positive results in Phase 3 trial for small cell lung cancer, significantly extending patient survival compared to chemotherapy [2][3] - The trial involved 509 patients, with Imdelltra reducing the risk of death by 40%, leading to an average survival of 13.6 months versus 8.3 months for chemotherapy [2][3] - Imdelltra also demonstrated a 29% reduction in the risk of disease progression or death, with improved patient-reported symptoms and a lower incidence of severe adverse events compared to chemotherapy [3][2] - Goldman Sachs rates Amgen as "Buy" with a 12-month target price of $400, indicating a 38% upside potential from the June 3 closing price [3] Group 2: Regeneron Pharmaceuticals (REGN.US) - Regeneron's linvoseltamab shows promising results in Phase 1b LINKER-MM2 trial for relapsed/refractory multiple myeloma, achieving an 85% objective response rate (ORR) when combined with bortezomib [4][5] - The combination therapy demonstrated a 50% complete response rate (CR) and a 78% six-month progression-free survival (PFS) rate [4] - In another cohort with carfilzomib, linvoseltamab achieved a 90% ORR and a 76% CR rate, with an estimated 12-month PFS rate of 83% [7] - Goldman Sachs rates Regeneron as "Buy" with a 12-month target price of $804, indicating a 35% upside potential from the June 3 closing price [8] Group 3: Relay Therapeutics (RLAY.US) - Relay's RLY-2608 combined with fulvestrant shows encouraging results in treating PIK3CA-mutated HR+/HER2- advanced breast cancer, with a median PFS of 10.3 months [9][10] - The trial included 118 patients, with a clinical benefit rate of 67% and an objective response rate of 67% in patients with kinase mutations [9][10] - Goldman Sachs rates Relay as "Buy" with a 12-month target price of $11, indicating a 234% upside potential from the June 3 closing price [11]

Core Insights - Regeneron Pharmaceuticals, Inc. announced promising initial results from the early-stage study of oncology drug linvoseltamab, particularly in patients with relapsed/refractory multiple myeloma [1][2] Group 1: Study Results - The LINKER-MM2 trial showed linvoseltamab combined with carfilzomib or bortezomib yielded high response rates in earlier treatment lines for relapsed/refractory multiple myeloma [2] - Efficacy results indicated a 90% objective response rate (ORR) and a 76% complete response (CR) at a median follow-up of 15 months [6] - Among patients treated with linvoseltamab and bortezomib, an 85% ORR was observed with 50% achieving CR [7] Group 2: Patient Demographics - The study included patients who had progressed after at least two lines of therapy, with many being double-class refractory or triple-class exposed [4] - 48% of enrolled patients had baseline soft tissue plasmacytomas, and 39% were over 75 years old, indicating a high-risk patient population [5] Group 3: Regulatory Developments - The European Commission granted conditional marketing approval for linvoseltamab under the brand name Lynozyfic for adults with relapsed/refractory multiple myeloma [8] - The FDA has accepted the resubmission of the Biologics License Application (BLA) for linvoseltamab, with a target action date of July 10, 2025 [9] Group 4: Oncology Portfolio Expansion - Regeneron is focused on strengthening its oncology portfolio, which includes Libtayo for various cancers [10] - The approval of odronextamab for treating relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma has also contributed to the oncology franchise [11] Group 5: Market Competition - The decline in sales of Regeneron's lead drug Eylea is a concern, attributed to competition from Roche's Vabysmo, which has significantly impacted Eylea's market share [12][13]

Core Insights - Regeneron Pharmaceuticals announced initial results from the Phase 1b LINKER-MM2 trial evaluating linvoseltamab in combination with proteasome inhibitors for relapsed/refractory multiple myeloma, showing high response rates [1][2] Summary by Sections Trial Overview - The LINKER-MM2 trial is a Phase 1b, open-label study assessing linvoseltamab combined with carfilzomib or bortezomib in patients with relapsed/refractory multiple myeloma who have progressed after at least two lines of therapy [9][11] Efficacy Results - In the carfilzomib cohort, 90% objective response rate (ORR) was observed with 76% achieving complete response (CR) after a median follow-up of 15 months [3] - In the bortezomib cohort, an 85% ORR was reported with 50% achieving CR after a median follow-up of 9 months [4] Safety Profile - Common treatment-emergent adverse events (TEAEs) in the carfilzomib cohort included neutropenia (65%), cytokine release syndrome (CRS; 61%), and infections (91%) [3] - In the bortezomib cohort, the most common TEAEs were CRS (58%), neutropenia (54%), and infections (75%) [5] Future Directions - A registrational, randomized Phase 3 trial is planned to investigate the combination of linvoseltamab and carfilzomib against standard-of-care treatments [3] - The FDA is reviewing the Biologics License Application for linvoseltamab in the U.S., with a target action date of July 10, 2025 [7] Market Context - Multiple myeloma is the second most common blood cancer, with over 187,000 new cases diagnosed globally each year [8] - Despite treatment advances, multiple myeloma remains incurable, necessitating ongoing research and development of new therapies [8]

Core Insights - Regeneron Pharmaceuticals is set to present new data from its oncology and hematology portfolio at the 2025 ASCO Annual Meeting, focusing on checkpoint inhibitors and bispecific antibodies for difficult-to-treat cancers [1][2][3] Oncology Developments - The company will showcase 18 presentations, including updates on the PD-1 inhibitor Libtayo and the investigational bispecific antibody linvoseltamab, which has shown promise in relapsed or refractory multiple myeloma [1][2] - Notable presentations include the Phase 3 C-POST trial results for Libtayo in high-risk cutaneous squamous cell carcinoma, scheduled for an oral session on May 31 [2][3] - Investigational combinations of linvoseltamab with proteasome inhibitors will also be highlighted in rapid oral presentations on June 2 [3] Hematology Insights - Regeneron will debut results from the LINKER-MM2 trial, exploring linvoseltamab combinations with carfilzomib or bortezomib in relapsed/refractory multiple myeloma [3][4] - The company will present findings from a randomized Phase 2 trial of vidutolimod in combination with anti-PD-1 therapy for stage 3 resectable melanoma on June 3 [4] Pipeline Overview - Regeneron's oncology pipeline includes a range of investigational therapies targeting over 30 types of solid tumors and blood cancers, with nearly half of its pipeline dedicated to oncology assets [11][26] - The company emphasizes its commitment to transforming cancer treatment through innovative therapies and collaborations [12][26] Regulatory Status - Libtayo is currently FDA-approved for several indications, while linvoseltamab and odronextamab are under review with target action dates of July 10, 2025, and July 30, 2025, respectively [9][11]

Core Opinion - Regeneron Pharmaceuticals, Inc. has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use for its pipeline candidate linvoseltamab, aimed at treating adults with relapsed and refractory multiple myeloma [1][2] Pipeline Candidate - Linvoseltamab is a bispecific antibody designed to activate T-cells against multiple myeloma cells by targeting B-cell maturation antigen [5] - The recommendation for conditional marketing authorization is for patients who have undergone at least three prior therapies and have shown disease progression [2] Regulatory Developments - The FDA has accepted the biologics license application for linvoseltamab, with a target action date set for July 10, 2025 [6] - The acceptance follows the resolution of manufacturing issues identified in a previous complete response letter [7] Clinical Trials - Linvoseltamab is undergoing a broad clinical development program, including a phase Ib study and a phase III confirmatory study [8][7] Oncology Portfolio Expansion - Regeneron is actively working to strengthen its oncology portfolio, which includes Libtayo and the recently approved odronextamab for treating relapsed or refractory follicular lymphoma and diffuse large B-cell lymphoma [9][10] - The FDA has also accepted the resubmission of the BLA for odronextamab, with a target action date of July 30, 2025 [11] Financial Performance - Regeneron’s shares have declined by 30.5% over the past year, contrasting with a 6.7% decline in the medical-biomedical genetics industry [3] - The company reported better-than-expected results for the fourth quarter, but faces challenges due to declining sales of its lead drug, Eylea, which is under pressure from competition [13]

Core Viewpoint - Regeneron Pharmaceuticals has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use recommending conditional marketing authorization for linvoseltamab to treat adults with relapsed and refractory multiple myeloma who have undergone at least three prior therapies [1][2] Summary by Sections Clinical Development - Linvoseltamab is an investigational bispecific antibody targeting B-cell maturation antigen (BCMA) and CD3, designed to activate T-cells to kill cancer cells [4] - The pivotal LINKER-MM1 trial involved 282 patients with relapsed and refractory multiple myeloma, focusing on safety, tolerability, and anti-tumor activity [5][6] - The trial's primary endpoint is the objective response rate, with secondary endpoints including duration of response and overall survival [5] Regulatory Status - The FDA has accepted the Biologics License Application for linvoseltamab, with a target action date set for July 10, 2025 [2] - The European Commission is expected to make a final decision regarding the marketing authorization in the coming months [1] Disease Context - Multiple myeloma is the second most common blood cancer, with over 35,000 new cases diagnosed annually in Europe and 187,000 globally [3] - The disease is characterized by the proliferation of cancerous plasma cells, leading to severe health complications [3] Treatment Landscape - Current treatments for multiple myeloma are not curative, and most patients will eventually require additional therapies due to disease progression [3] - Linvoseltamab is being evaluated not only as a monotherapy but also in combination with other treatments across various lines of therapy [7]