Joseph R. Biden Jr. achieved victory offering a message of healing and unity. He will return to Washington facing a daunting set of crises.
— New York Times: Top Stories
Categories
Biden wins presidency
Author: Michelle Dryden
Kody Workman, 33, and his girlfriend of 3 years, Kelly Castille, 34, were snorkeling on the seafloor in Negril, Jamaica, on Oct. 1 when Workman popped the question.
— FOX News
JetBlue Adds 25 Additional Flights from the New York Area to Florida, California, and Top VFR Markets in the Caribbean Over Peak Thanksgiving Travel Dates
NEW YORK–(BUSINESS WIRE)–JetBlue (NASDAQ: JBLU) today announced it is expanding service from New York City over the peak Thanksgiving weekend, with additional nonstop flights from New York, Newark and Westchester County airports. Additions include Florida destinations like Fort Lauderdale, Fort Myers, Orlando and Tampa, and more frequency in popular VFR markets like Port-au-Prince, San Juan, Santiago and Santo Domingo. Plus high-demand transcontinental routes to Los Angeles and San Francisco.
These additional 25 flights will operate between November 20th and November 30th, as part of JetBlue’s strategy to add capacity in routes with strong potential for leisure and VFR demand.
Thanksgiving holiday demand routes include:
- New York City (JFK) – Los Angeles
- New York City (JFK) – Port-au-Prince
- New York City (JFK) – Santo Domingo
- New York City (JFK) – San Francisco
- New York City (JFK) – San Juan
- New York City (JFK) – Santiago
- Newark -– Fort Lauderdale
- Newark – Orlando
- Newark – Fort Myers
- Newark – Tampa
- Westchester County – Fort Lauderdale
- Westchester County – Orlando
“As we head toward the holidays, we’re seeing signs of strong demand in certain markets. To help get more customers to their destinations and capture more revenue during this important time of year, we are adding additional flights over Thanksgiving weekend,” said Scott Laurence, head of revenue and planning, JetBlue.
The announcement for additional New York area flying comes after the airline revealed a lineup of over 60 new routes this year, including new nonstop destinations and expanded Mint service in Newark and Los Angeles. Each route plays to JetBlue’s strengths in the airline’s focus cities, in Florida, Latin America and the Caribbean or on cross-country – or transcontinental – flying. Every market has been identified as one in which JetBlue anticipates increasing demand for leisure travel.
About JetBlue Airways
JetBlue is New York’s Hometown Airline®, and a leading carrier in Boston, Fort Lauderdale-Hollywood, Los Angeles, Orlando, and San Juan. JetBlue carries customers across the U.S., Caribbean, and Latin America. For more information, visit jetblue.com.
Contacts
JetBlue Corporate Comm.
(718) 709-3089
The Texas Longhorns band will not play the school’s spirit song during the football team’s final two home games of the season over the controversy surrounding the music.
The University of Texas’ Longhorn Band will not perform at either of the school’s remaining home football games, according to a report from the Austin American-Statesman’s Brian Davis.
Per the Statesman, Doug Dempster, dean of the College of Fine Arts, said the alma mater will continue to be played over loudspeakers at Darrell K Royal-Texas Memorial Stadium for the remainder of the season.
This decision comes after the Longhorn Band did not perform in Texas’ win over Baylor on Oct. 24, when around half of the band’s members said they would not be comfortable performing the alma mater because of its roots to racist minstrel shows.
The song’s controversy extended to the team during the first several weeks of the season, when most Texas football players left the field immediately after games and did not participate in the playing of “The Eyes.” After athletic director Chris Del Conte met with the team before Texas’ win over Baylor, all players have remained on the field for the song after each of the past two games.
The Longhorns take on West Virginia in their second-to-last home game Saturday.
— FOX News
Joe Biden is leading in Nevada and Arizona and threatening to erase President Trump’s advantage in Pennsylvania. The Trump team is pressing legal challenges in several states.
— NYT: Top Stories
It’s not too late to end up on the right side of history.
Speaking from the White House briefing room on Thursday night, President Trump tried to delegitimize the 2020 election. This attempt may have been shuddersome, disgraceful and dangerous. But there’s one thing it was not: a surprise.
On the contrary. It was tediously predictable, exactly what you’d expect of a man who has spent four years lumbering through Washington, crushing custom after custom and norm after norm. As Trump faltered on the brink of losing a presidential election — the first incumbent to do so in 28 years — he declared, baselessly, that absentee votes legitimately cast were fraudulent; that the diligent workers paid to count those votes were doing something nefarious; and that the “election apparatus” in the still-unresolved states were controlled by Democrats. (They are not. Georgia’s secretary of state, for one, is a Republican.)
“They are trying to steal an election,” Trump said, speaking (I think) of ballot counters in Detroit and Philadelphia. “They are trying to rig an election. We can’t let that happen.”
But here’s my question for Republicans: Are they going to let this happen? Allow the head of their party to challenge the integrity of an election with record-breaking participation rates — in the midst of a pandemic, no less — just because he despises the result?
They’ve allowed just about everything else and given this demagogue a rather comfortable home; perhaps Trump’s words right now will hardly shock them. Faced with the prospect of losing an election, he’s now doing what demagogues do.
We just haven’t seen the likes of it in the United States.
What Trump said on Thursday night was historic, and not in a good way. These past four years, the president has done his best to weaken the foundations of democracy. But on the evening of Nov. 5, he seemed hellbent on breaking the 244-year-old thing itself. Telling your nation that the free election it just had is a sham — that’s taking aim at the head and heart.
- The election. And its impact on you
Back in June, I wrote that you could see Trump trying, already, to make an autocratic lunge for power. He had replaced the last of his honorable civil servants and cabinet officials with a gallery of dupes, dopes and devotees. He had dispatched Attorney General William Barr to do his bidding at the Department of Justice. He had gotten rid of five inspectors general. He had used the military to clear a public square of protesters. He had found an ally to purge the heads of Radio Free Europe and its three cousins, in what seemed like a spooky bid to make his own version of state-run TV.
As the election approached, he and his allies did everything they could to disenfranchise Democratic voters. Their efforts do not appear to have been sufficient. As I write, Joe Biden is poised to win enough Electoral College votes to win the 2020 election.
And so Trump is now doing what any aspiring strongman would: making a mad grab for power, the people’s choices be damned. He’ll use his lawyers, certainly. But just as important, he’ll use disinformation. From his Twitter feed. From the podium in the White House briefing room. From his own children — essential accessories in any banana republic — who are currently throwing Molotov cocktails on Twitter.
The company had to remove a tweet by Don Jr. on Thursday, who called on his father to “go to total war over the election to expose all of the fraud, cheating, dead/no longer in state voters, that has been going on for far too long.” (And perhaps this goes without saying, but: Sic.)
More than ever, these falsehoods have consequences. Those who simply shrug them off don’t seem to care about their reach, their power, their ability to foment unrest. A Facebook group called “Stop the Steal” started on Wednesday and was shut down within the space of 22 hours, after the company learned that members were trying to incite violence. At that point, it had acquired over 320,000 followers, becoming one of the fastest-growing groups Facebook had ever seen.
Those who’ve supported Trump have one last chance to be on the right side of history.
A couple already have. And I’m betting more will join them, though it may be for the wrong reasons. On Thursday, after the president’s news conference, the New York Post ran a story about it under the headline “Downcast Trump makes baseless election fraud claims in White House address.” I do not think the paper’s owner, Rupert Murdoch, had a sudden flash of conscience. I suspect that he likes winners, and he suddenly senses that Trump isn’t one. If the president is a cult leader, now is the moment he’s demanding that his followers drink the Kool-Aid. Rupert decided he wasn’t all that thirsty.
Let’s see how many other Republicans decide they aren’t that thirsty either. Let’s see how many of them finally put country before party, deciding it’s more important — no, imperative — for American democracy to live.
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— Jennifer Senior has been an Op-Ed columnist since September 2018. She had been a daily book critic for The Times; before that, she spent many years as a staff writer for New York magazine. Her best-selling book, “All Joy and No Fun: The Paradox of Modern Parenthood,” has been translated into 12 languages. @JenSeniorNY
— NYT: Top Stories
Categories
Why Is California a Blue State?
Friday: For over 25 years, the state has been a Democratic stronghold. But it wasn’t always that way.
Good morning.
While the country anxiously awaits the results from a handful of states that will determine the outcome of the presidential election, it has been known since Tuesday evening that California’s 55 electoral votes would go to Joe Biden.
[Follow the latest election updates from across the country here.]
It might come as a surprise then, that California was once considered a red state until the 1990s. From 1952 to 1988, the state gave rise to Republicans like Richard Nixon and Ronald Reagan. During that period, only one Democratic candidate, Lyndon B. Johnson, took the state.
This all changed in 1994, when the backlash against the passing of Proposition 187, which prohibited undocumented immigrants from accessing public services, activated a generation of Latino voters. After the proposition passed, thousands of people marched through downtown Los Angeles protesting the measure. All over the state, students organized grass-roots movements and walked out of classrooms. In 1997, Proposition 187 was ruled unconstitutional and never adopted into law.
“California Republicans embarked on an anti-immigration agenda that alienated Latino voters and drove them into the open arms of the Democratic Party,” the public opinion group Latino Decisions said in a report, calling it the “Prop 187 Effect.”
“We are a blue state because we’ve had a growing share of Latinos and Asian-Americans since the mid ’90s and after Proposition 187 they became more Democratic,” said Mindy Romero, director of the Center for Inclusive Democracy at the University of Southern California.
And the state is only getting bluer, with the number of Democrats increasing this year to 46 percent compared with 45 percent in 2016.
Likely voters are still disproportionately white. While Latinos make up 35 percent of the state’s population they make up just 21 percent of likely voters. But that makes them the second largest group of voters in the state by a large margin.
“In terms of sheer numbers, it’s Latinos,” Ms. Romero said. “California is a lock on the electoral map for Democrats and for Biden. A big part of that story is the growth of historically underrepresented populations and the growth of Latinos in particular in California.”
While Ms. Romero says it’s too early to analyze this year’s voter turnout rates, she thinks there will be an even more representative electorate this year. “In 2016, we saw the highest share of the electorate for Latinos that we’ve ever seen,” she said. “And I think we’ll see that again in 2020.”
— NYT: Top Stories
Approval based on Phase 3 CheckMate -9LA trial results showing superior overall survival in patients with metastatic non-small cell lung cancer, regardless of PD-L1 expression or tumor histologies
European Commission decision marks the first time a dual immunotherapy with limited chemotherapy is approved for patients with non-small cell lung cancer in the EU
Opdivo plus Yervoy-based combinations now indicated in the EU for three different advanced cancer types: non-small cell lung cancer, melanoma and renal cell carcinoma
PRINCETON, N.J.–(BUSINESS WIRE)–$BMY #BMS—Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has approved Opdivo (nivolumab) plus Yervoy (ipilimumab) with two cycles of platinum-based chemotherapy for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have no sensitizing epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation. The combination of Opdivo plus Yervoy with two cycles of chemotherapy is the first dual immunotherapy-based treatment option approved for patients in the European Union (EU) with this disease.
The EC’s decision is based on results from the Phase 3 CheckMate -9LA trial, which met its primary endpoint of superior overall survival (OS), as well as secondary endpoints of progression-free survival (PFS) and overall response rate (ORR), for the combination of Opdivo plus Yervoy, given concomitantly with two cycles of chemotherapy, versus chemotherapy alone. An improvement in duration of response (DoR) was also observed. The safety profile of Opdivo plus Yervoy and two cycles of chemotherapy was reflective of the known safety profiles of the immunotherapy and chemotherapy components in first-line NSCLC.
“With a complex disease like metastatic non-small cell lung cancer, the availability of different treatment options is critical for patients, who have diverse needs and challenges,” said Martin Reck, M.D., Ph.D., CheckMate -9LA study investigator, Lung Clinic Grosshansdorf, German Center of Lung Research. “In the CheckMate -9LA trial, combining nivolumab and ipilimumab with two cycles of chemotherapy resulted in clinically meaningful overall survival benefits, which were consistent across patients with non-small cell lung cancer, regardless of PD-L1 expression levels or tumor histologies. Following today’s approval, clinicians in the EU will be able to offer patients a new option that may help achieve early disease control and improve survival.”
“The European Commission’s approval of Opdivo plus Yervoy with two cycles of chemotherapy is an important milestone for patients with metastatic non-small cell lung cancer who face a difficult prognosis despite recent advances,” said Abderrahim Oukessou, M.D., vice president, thoracic cancers development lead, Bristol Myers Squibb. “This innovative regimen is built on the only approved dual immunotherapy foundation. The combination of Opdivo plus Yervoy has previously demonstrated long-term survival outcomes across multiple cancer types, including melanoma and renal cell carcinoma. We look forward to collaborating with a broad range of European stakeholders to bring this unique combination of two potentially synergistic immunotherapies with chemotherapy to eligible patients with lung cancer.”
This decision marks the third indication for an Opdivo plus Yervoy-based regimen in the EU, following previous approvals in metastatic melanoma and advanced renal cell carcinoma (RCC). In addition to the EU, the combination of Opdivo plus Yervoy with two cycles of chemotherapy has been approved in 11 countries, including the U.S., for the first-line treatment of patients with metastatic NSCLC.
“Access to innovative medicines is key to improve outcomes for people impacted by lung cancer,” said Anne-Marie Baird, president of Lung Cancer Europe (LuCE). “We are pleased to see new treatment options approved that may potentially help more people with metastatic non-small cell lung cancer.”
Bristol Myers Squibb thanks the patients and investigators involved in the CheckMate -9LA clinical trial.
CheckMate -9LA Efficacy and Safety Results
In the CheckMate -9LA trial, an interim analysis with a minimum follow-up of 8.1 months for OS demonstrated:
- Opdivo plus Yervoy combined with two cycles of chemotherapy reduced the risk of death by 31% compared to chemotherapy alone [Hazard Ratio (HR): 0.69; 96.71% Confidence Interval (CI): 0.55 to 0.87; p=0.0006].
- Median PFS with the combination was 6.8 months compared to 5.0 months with chemotherapy alone (HR: 0.70; 97.48% CI: 0.57 to 0.86; p=0.0001).
- ORR was significantly higher for Opdivo plus Yervoy with two cycles of chemotherapy vs. chemotherapy alone: 38% vs. 25% (p=0.0003).
A subsequent analysis, with a minimum follow-up of 12.7 months, showed sustained improvements in OS compared to chemotherapy alone (HR: 0.66; 95% CI: 0.55 to 0.80).
The majority of select adverse reactions observed in patients who received Opdivo plus Yervoy with two cycles of chemotherapy were mild to moderate. Grade 3 or 4 treatment-related adverse events occurred in 47% of patients. The most frequent adverse reactions were fatigue (36%), nausea (26%), rash (25%), diarrhea (20%), pruritus (18%), decreased appetite (16%), hypothyroidism (15%) and vomiting (13%).
About CheckMate -9LA
CheckMate -9LA is an open-label, multi-center, randomized Phase 3 trial evaluating Opdivo (360 mg Q3W) plus Yervoy (1 mg/kg Q6W) combined with histology-based chemotherapy (two cycles) compared to chemotherapy alone (up to four cycles followed by optional pemetrexed maintenance therapy if eligible) as a first-line treatment in patients with metastatic non-small cell lung cancer (NSCLC) regardless of PD-L1 expression and histology. Patients in the experimental arm (n=361) were treated with dual immunotherapy for up to two years or until disease progression or unacceptable toxicity. Patients in the control arm (n=358) were treated with up to four cycles of chemotherapy and optional pemetrexed maintenance (if eligible) until disease progression or unacceptable toxicity.
The primary endpoint of the trial was overall survival (OS) in the intent-to-treat (ITT) population. Secondary hierarchical endpoints included progression-free survival (PFS) and overall response rate (ORR) as assessed by blinded independent review committee. Exploratory analyses from the study evaluated efficacy measures according to biomarkers.
About Lung Cancer
Lung cancer is the leading cause of cancer deaths globally. The two main types of lung cancer are non-small cell and small cell. Non-small cell lung cancer (NSCLC) is one of the most common types of lung cancer and accounts for up to 84% of diagnoses. Survival rates vary depending on the stage and type of the cancer when diagnosed. For patients diagnosed with metastatic NSCLC, the five-year survival rate is approximately 6%.
Bristol Myers Squibb: Advancing Cancer Research
At Bristol Myers Squibb, patients are at the center of everything we do. The goal of our cancer research is to increase patients’ quality of life, long-term survival and make cure a possibility. We harness our deep scientific experience, cutting-edge technologies and discovery platforms to discover, develop and deliver novel treatments for patients.
Building upon our transformative work and legacy in hematology and Immuno-Oncology that has changed survival expectations for many cancers, our researchers are advancing a deep and diverse pipeline across multiple modalities. In the field of immune cell therapy, this includes registrational CAR T cell agents for numerous diseases, and a growing early-stage pipeline that expands cell and gene therapy targets, and technologies. We are developing cancer treatments directed at key biological pathways using our protein homeostasis platform, a research capability that has been the basis of our approved therapies for multiple myeloma and several promising compounds in early- to mid-stage development. Our scientists are targeting different immune system pathways to address interactions between tumors, the microenvironment and the immune system to further expand upon the progress we have made and help more patients respond to treatment. Combining these approaches is key to delivering potential new options for the treatment of cancer and addressing the growing issue of resistance to immunotherapy. We source innovation internally, and in collaboration with academia, government, advocacy groups and biotechnology companies, to help make the promise of transformational medicines a reality for patients.
About Opdivo
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.
Opdivo’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression.
In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan and China. In October 2015, the Company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union.
About Yervoy
Yervoy is a recombinant, human monoclonal antibody that binds to the cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4). CTLA-4 is a negative regulator of T-cell activity. Yervoy binds to CTLA-4 and blocks the interaction of CTLA-4 with its ligands, CD80/CD86. Blockade of CTLA-4 has been shown to augment T-cell activation and proliferation, including the activation and proliferation of tumor infiltrating T-effector cells. Inhibition of CTLA-4 signaling can also reduce T-regulatory cell function, which may contribute to a general increase in T-cell responsiveness, including the anti-tumor immune response. On March 25, 2011, the U.S. Food and Drug Administration (FDA) approved Yervoy 3 mg/kg monotherapy for patients with unresectable or metastatic melanoma. Yervoy is approved for unresectable or metastatic melanoma in more than 50 countries. There is a broad, ongoing development program in place for Yervoy spanning multiple tumor types.
U.S. FDA-APPROVED INDICATIONS
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic melanoma.
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.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM).
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of patients with intermediate or poor risk, previously untreated advanced renal cell carcinoma (RCC).
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
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 patients receiving OPDIVO monotherapy, fatal cases of immune-mediated pneumonitis have occurred. Immune-mediated pneumonitis occurred in 3.1% (61/1994) of patients. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated pneumonitis occurred in 6% (25/407) of patients. In HCC patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated pneumonitis occurred in 10% (5/49) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated pneumonitis occurred in 4.4% (24/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated pneumonitis occurred in 1.7% (2/119) of patients. 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. The incidence and severity of immune-mediated pneumonitis in patients with malignant pleural mesothelioma treated with OPDIVO 3 mg/kg every 2 weeks with YERVOY 1 mg/kg every 6 weeks were similar to those occurring in NSCLC.
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. In patients receiving OPDIVO monotherapy, immune-mediated colitis occurred in 2.9% (58/1994) of patients. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated colitis occurred in 26% (107/407) of patients including three fatal cases. In HCC patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated colitis occurred in 10% (5/49) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated colitis occurred in 10% (52/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated colitis occurred in 7% (8/119) of patients.
In a separate Phase 3 trial of YERVOY 3 mg/kg, immune-mediated diarrhea/colitis occurred in 12% (62/511) of patients, including Grade 3-5 (7%).
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. For patients without HCC, withhold OPDIVO for Grade 2 and permanently discontinue OPDIVO for Grade 3 or 4. For patients with HCC, withhold OPDIVO and administer corticosteroids if AST/ALT is within normal limits at baseline and increases to >3 and up to 5 times the upper limit of normal (ULN), if AST/ALT is >1 and up to 3 times ULN at baseline and increases to >5 and up to 10 times the ULN, and if AST/ALT is >3 and up to 5 times ULN at baseline and increases to >8 and up to 10 times the ULN. Permanently discontinue OPDIVO and administer corticosteroids if AST or ALT increases to >10 times the ULN or total bilirubin increases >3 times the ULN. In patients receiving OPDIVO monotherapy, immune-mediated hepatitis occurred in 1.8% (35/1994) of patients. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated hepatitis occurred in 13% (51/407) of patients. In HCC patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated hepatitis occurred in 20% (10/49) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated hepatitis occurred in 7% (38/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated hepatitis occurred in 8% (10/119) of patients.
In a separate Phase 3 trial of YERVOY 3 mg/kg, immune-mediated hepatitis occurred in 4.1% (21/511) of patients, including Grade 3-5 (1.6%).
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.
In patients receiving OPDIVO monotherapy, hypophysitis occurred in 0.6% (12/1994) of patients. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, hypophysitis occurred in 9% (36/407) of patients. In HCC patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, hypophysitis occurred in 4% (2/49) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, hypophysitis occurred in 4.6% (25/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated hypophysitis occurred in 3.4% (4/119) of patients. In patients receiving OPDIVO monotherapy, adrenal insufficiency occurred in 1% (20/1994) of patients. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, adrenal insufficiency occurred in 5% (21/407) of patients. In HCC patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, adrenal insufficiency occurred in 18% (9/49) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, adrenal insufficiency occurred in 7% (41/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, adrenal insufficiency occurred in 5.9% (7/119) of patients. In patients receiving OPDIVO monotherapy, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 9% (171/1994) of patients. Hyperthyroidism occurred in 2.7% (54/1994) of patients receiving OPDIVO monotherapy. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 22% (89/407) of patients. Hyperthyroidism occurred in 8% (34/407) of patients receiving this dose of OPDIVO with YERVOY. In HCC patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 22% (11/49) of patients. Hyperthyroidism occurred in 10% (5/49) of patients receiving this dose of OPDIVO with YERVOY. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 22% (119/547) of patients. Hyperthyroidism occurred in 12% (66/547) of patients receiving this dose of OPDIVO with YERVOY.
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