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New Checkpoint Inhibitor Approvals for Non-Small Cell Lung Cancer

In the last few years, the number of therapies available for the treatment of metastatic non-small cell lung cancer (NSCLC) has drastically increased. Many of these new drugs have shown increased response rates over previous standard-of-care therapies. For patients without oncogenic drivers, checkpoint inhibitors have emerged as the treatment of choice.

Recently, new checkpoint inhibitor regimens were approved for the first-line treatment of patients with metastatic NSCLC. Based on CheckMate-227, one combination was approved for patients whose tumors express PD-L1 (≥1%) while the combination with limited chemotherapy was approved regardless of PD-L1 expression based on CheckMate-9LA. Furthermore, based on IMpower110, a monotherapy was approved for patients with high PD-L1 expression (>50%).

There have also been novel challenges for providers due to the COVID-19 pandemic. A number of regulatory bodies and research organizations have released guidance stating that, while it is important to maintain standard treatment of metastatic lung cancer, checkpoint inhibitor treatment schedules may be modified or delayed in order to reduce clinical visits.

How do you expect your practices to change in the future as a result of the new checkpoint inhibitor approvals? How have your treatment and prescribing practices changed during the pandemic?

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Live-attenuated lymphocytic choriomeningitis virus-based vaccines for active immunotherapy of HPV16-positive cancer

Infection with human papillomavirus (HPV) is associated with a variety of cancer types and limited therapy options. Therapeutic cancer vaccines targeting the HPV16 oncoproteins E6 and E7 have recently been ..... see more

Source : https://doi.org/10.1080/2162402X.2020.1809960

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Hyperprogressive disease rarely occurs during checkpoint inhibitor treatment for advanced melanoma

Hyperprogression, characterized by a rapid acceleration in tumor growth, is a novel pattern of progression recently described in patients treated with immune checkpoint inhibitors. This study aims to assess the ..... see more

Source : https://link.springer.com/article/10.1007/s00262-020-02716-3

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Pan-TGFβ inhibition by SAR439459 relieves immunosuppression and improves antitumor efficacy of PD-1 blockade

TGFβ is a pleiotropic cytokine that may have both tumor inhibiting and tumor promoting properties, depending on tissue and cellular context. Emerging data support a role for TGFβ in suppression ..... see more

Source : https://doi.org/10.1080/2162402X.2020.1811605

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Inflammasome Deletion Promotes Anti-tumor NK Cell Function in an IL-1/IL-18 Independent Way in Murine Invasive Breast Cancer

Inflammasomes are molecular complexes that trigger an inflammatory response upon detection of pathogens or danger signals. Recent studies suggest that they are also involved in cancer progression. However, their roles ..... see more

Source : https://www.frontiersin.org/articles/10.3389/fonc.2020.01683/full

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Therapeutic efficacy and safety of a human fusion construct targeting the TWEAK receptor Fn14 and containing a modified granzyme B

Background Antibody-drug conjugates are an exceptional and useful therapeutic tool for multiple diseases, particularly for cancer treatment. We previously showed that the fusion of the serine protease granzyme B (GrB), ..... see more

Source : https://jitc.bmj.com/content/8/2/e001138?rss=1

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42-Year-Old Female with Fecal and Urinary Incontinence

Maggie, a 42-year-old female, presents complaining of leg weakness accompanied by fecal and urinary incontinence. Her medical history includes ..... see more

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Reviving up dendritic cells can run cancer immune wheel in non-small cell lung cancer: a prospective two-arm study

Lung cancer is the number one cause of cancer-related deaths. Dendritic cells (DCs) are heterogeneous components of innate immunity that play a crucial role in the anti-tumor T cell immunity ..... see more

Source : https://link.springer.com/article/10.1007/s00262-020-02704-7

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Commentary: Safety and feasibility of CRISPR-edited T cells in patients with refractory non-small-cell lung cancer

CRISPR/Cas9 ribonucleoprotein-mediated editing has been used to disrupt the PDCD1gene encoding programmed cell death-1 (PD-1) in human T cells, resulting in asignificantly reduced PD-1 expression without affecting T cell viability ..... see more

Source : https://doi.org/10.3389/fonc.2020.01726

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CyTOF mass cytometry reveals phenotypically distinct human blood neutrophil populations differentially correlated with melanoma stage

Background Understanding neutrophil heterogeneity and its relationship to disease progression has become a recent focus of cancer research. Indeed, several studies have identified neutrophil subpopulations associated with protumoral or antitumoral ..... see more

Source : https://jitc.bmj.com/content/8/2/e000473

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Immunotherapy with NK cells: recent developments in gene modification open up new avenues

ABSTRACT Chimeric antigen receptor (CAR)-T cell therapies have achieved remarkable success. However, application-related toxicities, such as cytokine release syndrome or neurotoxicity, moved natural killer (NK) cells into focus as novel ..... see more

Source : https://www.tandfonline.com/doi/full/10.1080/2162402X.2020.1777651

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Generation of GM-CSF-producing antigen-presenting cells that induce a cytotoxic T cell-mediated antitumor response

Immunotherapy using dendritic cells (DCs) is a promising treatment modality for cancer. However, the limited number of functional DCs from peripheral blood has been linked to the unsatisfactory clinical efficacies ..... see more

Source : https://www.tandfonline.com/doi/full/10.1080/2162402X.2020.1814620

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Circulating Tumor DNA Analysis to Assess Risk of Progression after Long-term Response to PD-(L)1 Blockade in NSCLC

Purpose: Treatment with PD-(L)1 blockade can produce remarkably durable responses in patients with non-small cell lung cancer (NSCLC). However, a significant fraction of long-term responders ultimately progress and predictors of ..... see more

Source : https://clincancerres.aacrjournals.org/content/26/12/2849

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PD-1 checkpoint blockade in advanced melanoma patients: NK cells, monocytic subsets and host PD-L1 expression as predictive biomarker candidates

Blockade of the PD-1 receptor has revolutionized the treatment of metastatic melanoma, with significant increases in overall survival (OS) and a dramatic improvement in patient quality of life. Despite the ..... see more

Source : https://www.tandfonline.com/doi/full/10.1080/2162402X.2020.1786888

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OPDIVO® (nivolumab) + YERVOY® (ipilimumab)

Don't miss it - OS and DOR for a 1L r/m NSCLC treatment option

View clinical results for a 1L treatment option for certain NSCLC patients.
 ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ 
 
 
OPDIVO(R)(nivolumab) + YERVOY(R) (ipilimumab) logo
recurrent/metastatic non-small cell lung cancer icon
For patients with mNSCLC (PD-L1 ≥1%)
mDOR of 23.2 months among
OPDIVO® + YERVOY®
responders (pre-specified
descriptive analysis)1
See OPDIVO + YERVOY clinical trial results,
including duration of response, below.
In the primary analysis of Checkmate 227 in patients with PD-L1 expression ≥1%, the median OS was 17.1 months (95% CI: 15.0–20.1) with OPDIVO + YERVOY vs 14.9 months (95% CI:
​12​.7​–16​.7) with chemo (HR=0.79; 95% CI: 0.67–0.94; P=0.0066) at a minimum follow‑up of 29.3 months.1 In Checkmate 227 Part 1a, ORR and mDOR were pre‑specified descriptive analyses. The ORR in patients with PD‑L1 ≥1% was 36% (142/396, 95% CI: 31–41) CR=5.8%, PR=30.1% with OPDIVO + YERVOY and 30% (119/397, 95% CI: 26–35) CR=1.8%, PR=28.2% with chemo.1 Among responders, the mDOR for OPDIVO + YERVOY was 23.2 months (95% CI: 15.2–32.2) and 6.7 months (95% CI: 5.6–7.6) for chemo. Scroll to see mDOR data below.
recurrent/metastatic non-small cell lung cancer icon Indication
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD‑L1 (≥1%) as determined by an FDA‑approved test, with no EGFR or ALK genomic tumor aberrations.1
OPDIVO (10 mg/mL) and YERVOY (5 mg/mL) are injections for intravenous (IV) use.1,4
SELECT IMPORTANT SAFETY INFORMATION
Summary of Warnings and Precautions
OPDIVO is associated with the following Warnings and Precautions including immune‑mediated: pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and renal dysfunction, skin adverse reactions, encephalitis, other adverse reactions; infusion‑related reactions; complications of allogeneic hematopoietic stem cell transplantation (HSCT); embryo‑fetal toxicity; and increased mortality in patients with multiple myeloma when OPDIVO is added to thalidomide analogue and dexamethasone, which is not recommended outside of controlled clinical trials. YERVOY is associated with the following Warnings and Precautions: severe and fatal immune-mediated adverse reactions, infusion-related reactions, complications of allogeneic hematopoietic stem cell transplant after YERVOY, embryo‑fetal toxicity and risks associated when administered in combination with OPDIVO.
Please see additional Important Safety Information for OPDIVO and YERVOY below, and U.S. Full Prescribing Information for OPDIVO and YERVOY.
Checkmate 227: Part 1a Study Design1,2
Checkmate 227 overall response rate, duration of response, and time to response data
Patients with untreated brain metastases, carcinomatous meningitis, active autoimmune disease, or medical conditions requiring systemic immunosuppression were excluded1
Tumor specimens were evaluated prospectively using the PD-L1 IHC 28-8 pharmDx assay at a central laboratory1
 
In an extended OS analysis for Checkmate 227, median follow‑up was 43.1 months: Longest median follow-up of any I‑O–based combination in a phase 3 trial5
For patients with mNSCLC (PD-L1 ≥1%)
OPDIVO + YERVOY offers dual I-O durability and long-term survival: 33% of patients alive at 3 years1,5†
Checkmate 227: OS for PD-L1 ≥1% (extended follow-up analysis)1,2,5
Checkmate 9LA study design
Median PFS: 5.1 months (95% CI: ​4​.1​–​6.​3​) with OPDIVO + YERVOY and 5.6 months (95% CI: ​4.​6​–​5.​8​) with chemo alone; HR=0.82; 95% CI: 0.69–0.971‡
29% of patients enrolled had SQ disease; 71% had NSQ disease1
 
Serious Adverse Reactions
In Checkmate 227, serious adverse reactions occurred in 58% of patients (n=576). The most frequent (≥2%) serious adverse reactions were pneumonia, diarrhea/colitis, pneumonitis, hepatitis, pulmonary embolism, adrenal insufficiency, and hypophysitis. Fatal adverse reactions occurred in 1.7% of patients; these included events of pneumonitis (4 patients), myocarditis, acute kidney injury, shock, hyperglycemia, multi‑system organ failure, and renal failure.
Common Adverse Reactions
In Checkmate 227, the most common (≥20%) adverse reactions were fatigue (44%), rash (34%), decreased appetite (31%), musculoskeletal pain (27%), diarrhea/colitis (26%), dyspnea (26%), cough (23%), hepatitis (21%), nausea (21%), and pruritus (21%).
Please see additional Important Safety Information for OPDIVO and YERVOY below.
For patients with mNSCLC (PD-L1 ≥1%)
mDOR of 23.2 months among OPDIVO + YERVOY responders1
ORR was 36% (142/396) with OPDIVO + YERVOY and 30% (119/397) with chemo1,2
5.8% CR with OPDIVO + YERVOY and 1.8% with chemo2
Checkmate 227: mDOR and range (extended follow-up analysis)5
Checkmate 9LA study design
In Checkmate 227 Part 1a, PFS, ORR, and DOR were pre‑specified descriptive analyses. The primary efficacy outcome measure was OS1,3
The ORR was 36% (142/396, 95% CI: 31–41) CR=5.8%, PR=30.1% with OPDIVO + YERVOY and 30% (119/397, 95% CI: 26–35) CR=1.8%, PR=28.2% with chemo1-3
Median TTR was 2.0 months with OPDIVO + YERVOY and 1.6 months with chemo3
For more data by responders, visit
OPDIVOYERVOYmNSCLC.com
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IMPORTANT SAFETY INFORMATION

Severe and Fatal Immune-Mediated Adverse Reactions
 
Immune-mediated adverse reactions listed herein may not be inclusive of all possible severe and fatal immune-mediated adverse reactions.

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. While immune-mediated adverse reactions usually manifest during treatment, they can also occur at any time after starting or discontinuing YERVOY. Early identification and management are essential to ensure safe use of YERVOY. Monitor for signs and symptoms that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and before each dose. Institute medical management promptly, including specialty consultation as appropriate.

Withhold or permanently discontinue YERVOY depending on severity. In general, if YERVOY requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less followed by corticosteroid taper for at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reaction is not controlled with corticosteroid therapy. Institute hormone replacement therapy for endocrinopathies as warranted.

Immune-Mediated Pneumonitis

OPDIVO can cause immune-mediated pneumonitis. Fatal cases have been reported. Monitor patients for signs with radiographic imaging and for symptoms of pneumonitis. Administer corticosteroids for Grade 2 or more severe pneumonitis. Permanently discontinue for Grade 3 or 4 and withhold until resolution for Grade 2. In NSCLC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated pneumonitis occurred in 9% (50/576) of patients, including Grade 4 (0.5%), Grade 3 (3.5%), and Grade 2 (4.0%) immune-mediated pneumonitis. Four patients (0.7%) died due to pneumonitis. The incidence and severity of immune-mediated pneumonitis in patients with NSCLC treated with OPDIVO 360 mg every 3 weeks in combination with YERVOY 1 mg/kg every 6 weeks and 2 cycles of platinum-doublet chemotherapy were comparable to treatment with OPDIVO in combination with YERVOY only.

Immune-Mediated Colitis

OPDIVO can cause immune-mediated colitis. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 (of more than 5 days duration), 3, or 4 colitis. Withhold OPDIVO monotherapy for Grade 2 or 3 and permanently discontinue for Grade 4 or recurrent colitis upon re-initiation of OPDIVO. When administered with YERVOY, withhold OPDIVO and YERVOY for Grade 2 and permanently discontinue for Grade 3 or 4 or recurrent colitis. 

Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Addition of an alternative immunosuppressive agent to the corticosteroid therapy, or replacement of the corticosteroid therapy, should be considered in corticosteroid-refractory immune-mediated colitis if other causes are excluded.

Immune-Mediated Hepatitis

OPDIVO can cause immune-mediated hepatitis. Monitor patients for abnormal liver tests prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater transaminase elevations. Withhold OPDIVO for Grade 2 and permanently discontinue OPDIVO for Grade 3 or 4.

Immune-Mediated Endocrinopathies

OPDIVO can cause immune-mediated hypophysitis, immune-mediated adrenal insufficiency, autoimmune thyroid disorders, and Type 1 diabetes mellitus. Monitor patients for signs and symptoms of hypophysitis, signs and symptoms of adrenal insufficiency, thyroid function prior to and periodically during treatment, and hyperglycemia. Withhold for Grades 2, 3, or 4 endocrinopathies if not clinically stable. Administer hormone replacement as clinically indicated and corticosteroids for Grade 2 or greater hypophysitis. Withhold for Grade 2 or 3 and permanently discontinue for Grade 4 hypophysitis. Administer corticosteroids for Grade 3 or 4 adrenal insufficiency. Withhold for Grade 2 and permanently discontinue for Grade 3 or 4 adrenal insufficiency. Administer hormone-replacement therapy for hypothyroidism. Initiate medical management for control of hyperthyroidism. Withhold OPDIVO for Grade 3 and permanently discontinue for Grade 4 hyperglycemia.

Immune-Mediated Nephritis and Renal Dysfunction

OPDIVO can cause immune-mediated nephritis. Monitor patients for elevated serum creatinine prior to and periodically during treatment. Administer corticosteroids for Grades 2-4 increased serum creatinine. Withhold OPDIVO for Grade 2 or 3 and permanently discontinue for Grade 4 increased serum creatinine. 

Immune-Mediated Skin and Dermatologic Adverse Reactions

OPDIVO can cause immune-mediated rash, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), some cases with fatal outcome. Administer corticosteroids for Grade 3 or 4 rash. Withhold for Grade 3 and permanently discontinue for Grade 4 rash. For symptoms or signs of SJS or TEN, withhold OPDIVO and refer the patient for specialized care for assessment and treatment; if confirmed, permanently discontinue. 

YERVOY can cause immune-mediated rash or dermatitis, including bullous and exfoliative dermatitis, Stevens Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-bullous exfoliative rashes. Withhold YERVOY until specialist assessment for Grade 2 and permanently discontinue for Grade 3 or 4 exfoliative or bullous dermatologic conditions.

Immune-Mediated Encephalitis

OPDIVO can cause immune-mediated encephalitis. Evaluation of patients with neurologic symptoms may include, but not be limited to, consultation with a neurologist, brain MRI, and lumbar puncture. Withhold OPDIVO in patients with new-onset moderate to severe neurologic signs or symptoms and evaluate to rule out other causes. If other etiologies are ruled out, administer corticosteroids and permanently discontinue OPDIVO for immune-mediated encephalitis. 

Other Immune-Mediated Adverse Reactions

Based on the severity of the adverse reaction, permanently discontinue or withhold OPDIVO, administer high-dose corticosteroids, and, if appropriate, initiate hormone-replacement therapy. Dose modifications for YERVOY for adverse reactions that require management different from these general guidelines are summarized as follows. Withhold for Grade 2 and permanently discontinue YERVOY for Grade 3 or 4 neurological toxicities. Withhold for Grade 2 and permanently discontinue YERVOY for Grade 3 or 4 myocarditis. Permanently discontinue YERVOY for Grade 2, 3, or 4 ophthalmologic  adverse reactions that do not improve to Grade 1 within 2 weeks while receiving topical therapy OR that require systemic therapy. Across clinical trials of OPDIVO in combination with YERVOY, the following clinically significant immune-mediated adverse reactions, some with fatal outcome, occurred in <1.0% of patients receiving OPDIVO: myocarditis, rhabdomyolysis, myositis, uveitis, iritis, pancreatitis, facial and abducens nerve paresis, demyelination, polymyalgia rheumatica, autoimmune neuropathy, Guillain-Barré syndrome, hypopituitarism, systemic inflammatory response syndrome, gastritis, duodenitis, sarcoidosis, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), motor dysfunction, vasculitis, aplastic anemia, pericarditis, and myasthenic syndrome. In addition to the immune-mediated adverse reactions listed above, across clinical trials of YERVOY monotherapy or in combination with OPDIVO, the following clinically significant immune-mediated adverse reactions, some with fatal outcome, occurred in <1% of patients unless otherwise specified: autoimmune neuropathy (2%), meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis, nerve paresis, angiopathy, temporal arteritis, pancreatitis (1.3%), arthritis, polymyositis, conjunctivitis, cytopenias (2.5%), eosinophilia (2.1%), erythema multiforme, hypersensitivity vasculitis, neurosensory hypoacusis, psoriasis, blepharitis, episcleritis, orbital myositis, and scleritis. Some cases of ocular IMARs have been associated with retinal detachment.
 
If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, which has been observed in patients receiving OPDIVO and YERVOY and may require treatment with systemic steroids to reduce the risk of permanent vision loss.

Infusion-Related Reactions

OPDIVO can cause severe infusion-related reactions, which have been reported in <1.0% of patients in clinical trials. Discontinue OPDIVO in patients with Grade 3 or 4 infusion-related reactions. Interrupt or slow the rate of infusion in patients with Grade 1 or 2. Severe infusion-related reactions can also occur with YERVOY. Discontinue YERVOY in patients with severe or life-threatening infusion reactions and interrupt or slow the rate of infusion in patients with mild or moderate infusion reactions. In patients receiving OPDIVO monotherapy as a 60-minute infusion,  infusion-related  reactions occurred in 6.4%  (127/1994) of patients. In a separate trial in which patients received OPDIVO monotherapy as a 60-minute infusion or a 30-minute infusion, infusion-related reactions occurred in 2.2% (8/368) and 2.7% (10/369) of patients, respectively. Additionally, 0.5% (2/368) and 1.4% (5/369) of patients, respectively, experienced adverse reactions within 48 hours of infusion that led to dose delay, permanent discontinuation or withholding of OPDIVO.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation

Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1 receptor blocking antibody or YERVOY. Transplant-related complications include hyperacute graft-versus-host-disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between PD-1 or CTLA-4 receptor blockade and allogeneic HSCT.

Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with a PD-1 receptor blocking antibody or YERVOY prior to or after an allogeneic HSCT.

Embryo-Fetal Toxicity

Based on mechanism of action, OPDIVO and YERVOY can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with OPDIVO or YERVOY and for at least 5 months after the last dose.

Increased Mortality in Patients with Multiple Myeloma when OPDIVO is Added to a Thalidomide Analogue and Dexamethasone

In clinical trials in patients with multiple myeloma, the addition of OPDIVO to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of patients with multiple myeloma with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials.

Lactation

It is not known whether OPDIVO or YERVOY is present in human milk. Because many drugs, including antibodies, are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from OPDIVO or YERVOY, advise women not to breastfeed during treatment and for at least 5 months after the last dose. 

Serious Adverse Reactions

In Checkmate 227, serious adverse reactions occurred in 58% of patients (n=576). The most frequent (≥2%) serious adverse reactions were pneumonia, diarrhea/colitis, pneumonitis, hepatitis, pulmonary embolism, adrenal insufficiency, and hypophysitis. Fatal adverse reactions occurred in 1.7% of patients; these included events of pneumonitis (4 patients), myocarditis, acute kidney injury, shock, hyperglycemia, multi-system organ failure, and renal failure. In Checkmate 9LA, serious adverse reactions occurred in 57% of patients (n=358). The most frequent (>2%) serious adverse reactions were pneumonia, diarrhea, febrile neutropenia, anemia, acute kidney injury, musculoskeletal pain, dyspnea, pneumonitis, and respiratory failure. Fatal adverse reactions occurred in 7 (2%) patients, and included hepatic toxicity, acute renal failure, sepsis, pneumonitis, diarrhea with hypokalemia, and massive hemoptysis in the setting of thrombocytopenia.

Common Adverse Reactions

In Checkmate 227, the most common (≥ 20%) adverse reactions were fatigue (44%), rash (34%), decreased appetite (31%), musculoskeletal pain (27%), diarrhea/colitis (26%), dyspnea (26%), cough (23%), hepatitis (21%), nausea (21%), and pruritus (21%). In Checkmate 9LA, the most common (>20%) adverse reactions were fatigue (49%), musculoskeletal pain (39%), nausea (32%), diarrhea (31%), rash (30%), decreased appetite (28%), constipation (21%), and pruritus (21%). 

Please see U.S. Full Prescribing Information for OPDIVO and YERVOY

Checkmate Trials and Patient Populations

Checkmate 227–previously untreated metastatic non-small cell lung cancer, in combination with YERVOY; Checkmate 9LA–previously untreated recurrent or metastatic non-small cell lung cancer in combination with YERVOY and 2 cycles of platinum-doublet chemotherapy by histology.

INDICATIONS

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab) and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

References

1. OPDIVO [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; 2020.
2. Hellmann MD, Paz‑Ares L, Bernabe Caro R, et al. Nivolumab plus ipilimumab in advanced non‑small‑cell lung cancer. N Engl J Med. 2019;381(21):2020‑2031.
3. Hellmann MD, Paz‑Ares L, Bernabe Caro R, et al. Nivolumab plus ipilimumab in advanced non‑small‑cell lung cancer (suppl). N Engl J Med. 2019;381(21):2020‑2031.
4. YERVOY [package insert]. Princeton, NJ: Bristol‑Myers Squibb Company; 2020.
5. Ramalingam SS, Ciuleanu TE, Pluzanski A, et al. Nivolumab + ipilimumab versus platinum‑doublet chemotherapy as first‑line treatment for advanced non‑small cell lung cancer: Three-year update from CheckMate 227 Part 1. Oral presentation at ASCO 2020. Abstract 9500.

© 2020 Bristol-Myers Squibb Company. All rights reserved.

7356US2001608-01-01 08/20

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Immune‐related signature predicts the prognosis and immunotherapy benefit in bladder cancer

Mengxue Yu Department of Biological Repositories, Zhongnan Hospital of Wuhan University, Wuhan, China Human Genetics Resource Preservation Center of Hubei Province, Wuhan, China Human Genetics Resource Preservation Center of Wuhan ..... see more

Source : https://onlinelibrary.wiley.com/doi/full/10.1002/cam4.3400

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Circulating Tumor DNA Analysis to Assess Risk of Progression after Long-term Response to PD-(L)1 Blockade in NSCLC

Purpose: Treatment with PD-(L)1 blockade can produce remarkably durable responses in patients with non-small cell lung cancer (NSCLC). However, a significant fraction of long-term responders ultimately progress and predictors of ..... see more

Source : https://clincancerres.aacrjournals.org/content/26/12/2849

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Anti-tumor immunity influences cancer cell reliance upon ATG7

Macroautophagy (autophagy) is an essential cellular catabolic process required for survival under conditions of starvation. The role of autophagy in cancer is complex, context-dependent and at times contradictory, as it ..... see more

Source : https://www.tandfonline.com/doi/full/10.1080/2162402X.2020.1800162