Keytruda (pembrolizumab) / Merck (MSD) - LARVOL DELTA

Pembrolizumab plus olaparib vs pembrolizumab plus chemotherapy after induction with pembrolizumab plus chemotherapy for locally recurrent inoperable or metastatic TNBC: Patient-reported outcomes from KEYLYNK-009 (ESMO-BC 2024) - P2 | "Methods Eligible pts received induction therapy with pembro 200 mg Q3W + chemo (carboplatin AUC 2 + gemcitabine 1000 mg/m2 on days 1 and 8 per 21-day cycle) for 4–6 cycles. Table: 198P Between-group difference in change from baseline to wk 18 least-squares mean (95% CI)a (Pembro + Ola vs Pembro + Chemo) QLQ-C30 GHS/QoL −3.28 (−7.69 to 1.12) QLQ-C30 physical functioning −0.16 (−4.89 to 4.56) QLQ-C30 emotional functioning 2.08 (−3.16 to 7.31) QLQ-BR23 systemic therapy side effects 0.93 (−2.20 to 4.06) EQ-5D-5L VAS −0.37 (−4.03 to 3.28) TTD HR (95% CI)b (Pembro + Ola vs Pembro + Chemo) QLQ-C30 GHS/QoL 1.78 (1.16–2.71) QLQ-C30 physical functioning 1.01 (0.61–1.69) QLQ-C30 emotional functioning 1.08 (0.69–1.71) QLQ-BR23 systemic therapy side effects 1.76 (0.88–3.53) aBased on a constrained longitudinal data analysis model (cLDA).bBased on stratified Cox regression model. Conclusions In pts with metastatic TNBC, stopping chemo in pts with responding or stable disease and..."

Clinical • Metastases • Patient reported outcomes • Triple Negative Breast Cancer

A phase I pilot study of personalized neoantigen peptide-based vaccine in combination with pembrolizumab in advanced solid tumors (PNeoVCA). (ASCO 2024) - P1 | "Clinical Trial Registration Number: NCT05269381"

Clinical • Combination therapy • Metastases • P1 data • Tumor-specific neoantigens • Oncology • Solid Tumor

Enhancing Therapeutic Efficacy and Safety of Immune Checkpoint Inhibition for Bladder Cancer: A Comparative Analysis of Injectable vs. Intravesical Administration. (PubMed, Int J Mol Sci) - "Intravesical administration of ICIs offers a potential solution, with recent studies demonstrating the feasibility and efficacy of intravesical pembrolizumab...In conclusion, intravesical immunotherapy presents a promising avenue for BC treatment, offering enhanced therapeutic effectiveness while minimizing systemic toxicity. Continued research efforts are essential to validate these findings and optimize intravesical immunotherapy's role in BC management, ultimately improving patient outcomes."

Checkpoint inhibition • Clinical • Journal • Review • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

KEYNOTE-667: UPDATED RESULTS FROM THE PHASE 2 STUDY OF PEMBROLIZUMAB IN CHILDREN AND YOUNG ADULTS WITH HIGH-RISK CLASSICAL HODGKIN LYMPHOMA WITH SLOW EARLY RESPONSE (SER) TO FRONT-LINE CHEMOTHERAPY (EHA 2024) - P2 | "KEYNOTE-667(NCT03407144) is an open-label phase 2 study including the evaluation of safety and efficacy ofpembrolizumab (pembro) plus cyclophosphamide, vincristine, prednisone/prednisolone, and dacarbazine(COPDAC-28) consolidation in pediatric pts with high-risk cHL and SER...Pts received induction with vincristine, etoposide,prednisone/prednisolone, and doxorubicin (OEPA) for 2 cycles and (early) response was assessed by PET andCT/MRI... In this updated analysis for pts with high-risk cHL and SER to front-line OEPA, consolidation with pembro plusCOPDAC-28 continued to have manageable safety and promising antitumor activity. Among pts with a LRA,71% had a PET-negative response by BICR and were spared RT. These results continue to support the potentialof pembro and COPDAC-28 consolidation to augment responses in the high-risk cHL population."

Clinical • P2 data • Endocrine Disorders • Gastroenterology • Gastrointestinal Disorder • Hematological Malignancies • Hodgkin Lymphoma • Immunology • Lymphoma • Oncology • Pediatrics • Pneumonia

Lung-MAP S1800D: A phase II/III study of N-803 (ALT-803) plus pembrolizumab versus standard of care in participants with stage IV or recurrent non-small cell lung cancer (NSCLC) previously treated with anti-PD-1 or anti-PD-L1 therapy. (ASCO 2024) - P2/3 | "Clinical Trial Registration Number: NCT05096663"

Metastases • P2/3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Metastatic patterns and treatment options for head and neck cutaneous squamous cell carcinoma (Review). (PubMed, Mol Clin Oncol) - "Current findings on tumor molecular targets have suggested the use of systemic treatments, particularly immunotherapy (such as cemiplimab, pembrolizumab and nivolumab), over radiotherapy or chemotherapy for this type of metastasis. Notably, there is an urgent need to identify patients who may benefit from local or systemic cancer treatments. The treatment of lymph node metastasis presents a therapeutic challenge and requires comprehensive management."

Journal • Metastases • Review • Genetic Disorders • Head and Neck Cancer • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Update on the Screening, Diagnosis, and Management of Cholangiocarcinoma. (PubMed, Gastroenterol Hepatol (N Y)) - "Treatments can vary among CCA subtypes but frequently involve systemic therapies such as gemcitabine and cisplatin with durvalumab or pembrolizumab. Targeted therapies may also be effective (eg, ivosidenib, pemigatinib, infigratinib, futibatinib) depending on the molecular alterations present...Although patients with CCA have traditionally had a poor prognosis, recent advances in treatment, including new systemic therapies and increased utilization of liver transplantation, have improved expected survival. This article reviews screening modalities, pros and cons of diagnostic techniques, and therapies that are currently available to treat patients with CCA."

Journal • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Fibrosis • Gastrointestinal Cancer • Hepatology • Immunology • Oncology • Solid Tumor • Transplantation

Diagnosis, management, and outcomes of immune checkpoint inhibitor induced acute interstitial nephritis: A single-center experience. (PubMed, J Oncol Pharm Pract) - "Rechallenge with IO after kidney irAE may be possible in some patients but requires careful evaluation on an individual basis."

Checkpoint inhibition • Journal • Acute Kidney Injury • Inherited Retinal Dystrophy • Nephrology • Oncology • Ophthalmology • Renal Disease

A digital pathology AI model to predict immune-oncology biomarker status and pembrolizumab response in a real-world cohort of patients with colorectal and breast cancer. (ASCO 2024) - No abstract available

Biomarker • Clinical • Real-world • Real-world evidence • Breast Cancer • Colorectal Cancer • Oncology • Solid Tumor

Enfortumab vedotin (EV) with pembrolizumab (P) versus chemotherapy (chemo) in previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC): Analysis of the cisplatin (cis)-ineligible population from EV-302/KEYNOTE-A39. (ASCO 2024) - P3 | "Clinical Trial Registration Number: NCT04223856"

Clinical • Metastases • Oncology • Solid Tumor • Urothelial Cancer

STELLAR-305: A randomized phase 2/3 study of zanzalintinib plus pembrolizumab versus pembrolizumab alone in patients with previously untreated PD-L1 positive recurrent/metastatic head and neck squamous cell carcinoma. (ASCO 2024) - P2/3 | "Clinical Trial Registration Number: NCT06082167"

Clinical • Metastases • P2/3 data • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

A Study of (Neo)Adjuvant V940 and Pembrolizumab in Cutaneous Squamous Cell Carcinoma (V940-007) (clinicaltrials.gov) - P2/3 | N=1012 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Apr 2029 ➔ May 2033

Combination therapy • Metastases • Monotherapy • Trial completion date • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Systemic Therapy for Melanoma: ASCO Guideline. (PubMed, J Clin Oncol) - "In the adjuvant setting, nivolumab or pembrolizumab should be offered to patients with resected stage IIIA/B/C/D BRAF wild-type cutaneous melanoma, while either of those two agents or the combination of dabrafenib and trametinib should be offered in BRAF-mutant disease. No recommendation could be made for or against the use of neoadjuvant therapy in cutaneous melanoma. In the unresectable/metastatic setting, ipilimumab plus nivolumab, nivolumab alone, or pembrolizumab alone should be offered to patients with BRAF wild-type cutaneous melanoma, while those three regimens or combination BRAF/MEK inhibitor therapy with dabrafenib/trametinib, encorafenib/binimetinib, or vemurafenib/cobimetinib should be offered in BRAF-mutant disease. Patients with mucosal melanoma may be offered the same therapies recommended for cutaneous melanoma. No recommendation could be made for or against specific therapy for uveal melanoma. Additional information is available at..."

Journal • Ocular Melanoma • Oncology • Solid Tumor

EFFICACY OF PEMBROLIZUMAB MONOTHERAPY AND IN COMBINATION WITH BCR INHIBITORS FOR RICHTER TRANSFORMATION OF CHRONIC LYMPHOCYTIC LEUKEMIA (EHA 2024) - "Sixteen patients went on to receive a BCR kinase inhibitor (ibrutinib [n=15], idelalisib [n=1]) in combinationwith pembrolizumab, after SD or PD on pembrolizumab monotherapy. This expanded analysis confirmed that pembrolizumab has modest single agent activity in RT. Combinationtherapy with pembrolizumab and a BCR kinase inhibitor is associated with increased efficacy (ORR >60%),similar to other reports. These results support further investigation of immune checkpoint inhibitor-basedcombination therapy in RT."

Clinical • Combination therapy • IO biomarker • Monotherapy • Anemia • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Leukopenia • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Pneumonia • Pulmonary Disease • Richter's Syndrome • Thrombocytopenia • TP53

Trial of LAVA-1207 in Patients With Therapy Refractory Metastatic Castration Resistant Prostate Cancer (mCRPC) Resistant Prostate Cancer (clinicaltrials.gov) - P1/2 | N=180 | Recruiting | Sponsor: Lava Therapeutics | N=66 ➔ 180 | Trial completion date: Mar 2024 ➔ Apr 2027 | Trial primary completion date: Sep 2023 ➔ Apr 2027

Enrollment change • Metastases • Trial completion date • Trial primary completion date • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Plasma versus tissue tumor mutational burden as biomarkers of durvalumab plus tremelimumab response in patients with metastatic colorectal cancer in the CO.26 trial. (PubMed, Clin Cancer Res) - "pTMB derived from either clonal or subclonal mutations may identify a group more likely to benefit from immunotherapy, though validation is required. Tissue TMB provided no predictive utility for immunotherapy in this trial."

Biomarker • IO biomarker • Journal • Metastases • Tumor mutational burden • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • TMB

What is the future of immune checkpoints inhibitors for metastatic triple negative breast cancers? (PubMed, Immunotherapy) - No abstract available

Journal • Metastases • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

SU2C-SARC032: A randomized trial of neoadjuvant RT and surgery with or without pembrolizumab for soft tissue sarcoma. (ASCO 2024) - P2 | "Clinical Trial Registration Number: NCT03092323"

Clinical • Surgery • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

THE ONCONEPHROLOGICAL PHENOTYPE OF FRENCH GUIANA: CASE OF THE WESTERN GUIANA HOSPITAL CENTER (NKF-SCM 2024) - "Drug therapy was based on immunotherapy, including 1st-line treatment with Pembrolizumab+Axitinib, Cabozantinib+nivolumab, Nivolumab+Implimumab and Pazopanib... Renal cancer is present in French Guiana, with characteristics similar to those described in metropolitan France. Late diagnosis, often at the metastatic stage, increases morbidity and mortality, and adds to the burden of care. Hence the need for special surveillance in this population with risk factors."

Clinical • IO biomarker • Anemia • Cardiovascular • Genetic Disorders • Genito-urinary Cancer • Hematological Disorders • Hypertension • Infectious Disease • Kidney Cancer • Obesity • Oncology • Renal Cell Carcinoma • Renal Disease • Septic Shock • Solid Tumor

Preliminary antitumor activity of COM701 in combination with COM902 and pembrolizumab in patients with MSS-CRC and liver metastases. (ASCO 2024) - P1 | "Clinical Trial Registration Number: NCT04354246."

Clinical • Combination therapy • Colorectal Cancer • Oncology

Pfizer Highlights Progress in Accelerating Breakthrough Cancer Medicines at ASCO 2024 Annual Meeting (Pfizer Press Release) - "Highlights from Pfizer’s genitourinary cancer portfolio will include updated data that continue to reinforce the potential of several recent priority launches, including PADCEV (enfortumab vedotin-ejfv) in combination with KEYTRUDA (pembrolizumab) in locally advanced/metastatic urothelial cancer, XTANDI (enzalutamide) in non-metastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high-risk for metastasis, and TALZENNA (talazoparib) in combination with XTANDI in metastatic castration-resistant prostate cancer (mCRPC) with homologous recombination repair (HRR) mutations. Additionally, updated Phase 1 data will be presented for the investigational enhancer of zeste homolog 2 (EZH2) inhibitor mevrometostat in combination with XTANDI in mCRPC; Pfizer anticipates initiating Phase 3 studies for this combination later this year."

Clinical data • New P3 trial • P1 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

PRESERVE-001: Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC (clinicaltrials.gov) - P1/2 | N=733 | Recruiting | Sponsor: OncoC4, Inc. | Trial completion date: Dec 2024 ➔ Dec 2027 | Trial primary completion date: Jun 2024 ➔ Jun 2026

Combination therapy • Metastases • Monotherapy • Trial completion date • Trial primary completion date • Adenoid Cystic Carcinoma • Breast Cancer • Cervical Cancer • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatocellular Cancer • Hepatology • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Renal Cell Carcinoma • Salivary Gland Cancer • Sarcoma • Small Cell Lung Cancer • Solid Tumor • Triple Negative Breast Cancer • Urothelial Cancer

Petosemtamab (MCLA-158) with pembrolizumab as first-line (1L) treatment of recurrent/metastatic (r/m) head and neck squamous cell carcinoma (HNSCC): Phase 2 study. (ASCO 2024) - P1/2 | "Clinical Trial Registration Number: NCT03526835"

Clinical • Metastases • P2 data • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

A Study to Assess Efficacy and Safety of Pembrolizumab With or Without MK- 2870 in Adult Participants With Resectable Non Small Cell Lung Cancer (NSCLC) Not Achieving Pathological Complete Response (pCR) (MK-2870-019) (clinicaltrials.gov) - P3 | N=780 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Surgery • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Impact of immunotherapy addition to dose density of neoadjuvant chemotherapy for triple-negative breast cancer: A retrospective, real-world study from multiple centres in London (UK) (ESMO-BC 2024) - "Results 78 patients received pembrolizumab plus neoadjuvant carboplatin-paclitaxel and epirubicin-cyclophosphamide. Conclusions Introduction of pembrolizumab resulted in additional toxicity, frequent dose reductions and delays in chemotherapy delivery. Frequent omission of immunotherapy doses highlights the complexity of managing toxicities arising from use of this new agent class."

Real-world • Real-world evidence • Retrospective data • Breast Cancer • Dermatology • Endocrine Disorders • Fatigue • Gastroenterology • Gastrointestinal Disorder • Immunology • Musculoskeletal Diseases • Nephrology • Oncology • Pain • Pneumonia • Solid Tumor • Triple Negative Breast Cancer