Top Takeaways from ASCO: Melanoma

“The results of a phase 3 trial presented during the Plenary Session at the ASCO Annual Meeting comparing combination nivolumab-ipilimumab treatment to nivolumab alone and ipilimumab alone was one of the most pivotal presentations on melanoma at the 2015 ASCO Annual Meeting.

“A second key melanoma study examined survival of patients undergoing SLNB who did or did not receive CLND. Several physicians shared their insights on the Top Takeaways from these findings with

“Jedd D. Wolchok, MD, PhD, chief of melanoma and immunotherapeutics service and the Lloyd J. Old Chair for Clinical Investigation at Memorial Sloan Kettering Cancer Center and a HemOnc Today Editorial Board member, presented the results of the CheckMate 067 study during the Plenary Session that compared the use of nivolumab alone to ipilimumab alone as well as to nivolumab plus ipilimumab. Nivolumab is a programmed death 1 (PD-1) checkpoint inhibitor and ipilimumab is a cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) checkpoint inhibitor.

“ ‘The most important data that came out — which is very clear — is that there’s no doubt now in anyone’s mind that anti-PD-1 beats anti-CTLA-4. Whether its nivolumab or pembrolizumab, it’s better than giving ipilimumab front-line,’ Sanjiv S. Agarwala, MD, chief of oncology and hematology at St. Luke’s Cancer Center, professor at Temple University School of Medicine and a HemOnc Today Editorial Board member, told Pembrolizumab is another anti-PD-1 immunotherapy indicated for melanoma.”

Melanoma at ASCO 2015: Immunotherapy Continues to Make Headlines

The biggest news in melanoma treatment from the 2015 American Society of Clinical Oncology (ASCO) annual meeting was undoubtedly the report from a large, phase III, randomized clinical trial that compared a combination of two ‘checkpoint inhibitor’ drugs—nivolumab (Opdivo) and ipilimumab (Yervoy)—with the same drugs given alone.

In the CheckMate-067 trial, 945 previously untreated patients with unresectable stage III or IV melanoma were assigned to Opdivo alone, Opdivo plus Yervoy, or Yervoy alone. Continue reading…

Small Cell Lung Cancer at ASCO: Some Welcome News

Small cell lung cancer (SCLC) is a fatal disease that has not seen new drug approvals for the last 17 years. Considering the relative success of ‘immune checkpoint inhibitors’ in non-small cell lung cancer (NSCLC), it is not surprising that several abstracts recently presented at the 2015 American Society of Clinical Oncology (ASCO) annual meeting were devoted to clinical trials testing these trendy, immune system-boosting drugs in people with SCLC. Continue reading…

FDA Grants Priority Review to Keytruda for Advanced NSCLC

“The FDA accepted for review the supplemental biologics license application of pembrolizumab for advanced non–small cell lung cancer, according to a press release from the drug’s manufacturer.

“Further, the FDA granted priority review and breakthrough therapy designation to pembrolizumab (Keytruda, Merck) — a humanized monoclonal antibody that blocks the interaction between programmed cell death-1 (PD-1) and its ligands, PD-L1 and PD-L2 — for advanced NSCLC with a target action date of October 2, 2015.

“The FDA will review the use of pembrolizumab in patients with advanced NSCLC whose disease has progressed on or after platinum chemotherapy and an FDA-approved therapy for epidermal growth factor receptor or ALK genomic tumor aberrations, if present.”

Tests for New Cancer Drugs Not Reliable Enough, Doctors Say

“Drugmakers including Bristol-Myers Squibb Co and Merck & Co are testing which patients will most benefit from new cancer treatments based on a protein found in their tumors, but that guide, known as a biomarker, may be too unreliable, researchers and health experts said.

“Bristol’s Opdivo and Merck’s Keytruda are both therapies designed to block a protein known as Programmed Death receptor (PD-1) that tumors use to evade the body’s natural defenses. Competitors Roche Holding, AstraZeneca and Pfizer also have similar drugs in an earlier stage of development. The drugmakers are conducting clinical trials that test patient tumors for a related protein called PD-L1.

“The new drugs are mainly aimed at patients with so-called solid tumors suffering from diseases including lung cancer and liver cancer. Lung cancer, the most common type, claims 1.8 million new cases each year worldwide. Sales of drugs to block PD-1 could reach $33 billion a year by 2022, according to Morningstar.”

New Class of Drugs Shows More Promise in Treating Cancer

“A new drug that unleashes the body’s immune system to attack tumors can prolong the lives of people with the most common form of lung cancer, doctors reported on Friday, the latest example of the significant results being achieved by this new class of medicines.

“In a separate study, researchers said they had found that a particular genetic signature in the tumor can help predict which patients could benefit from the immune-boosting drugs.

“The finding could potentially extend use of these drugs to some patients with colorectal cancer, prostate cancer and other tumors that have seemed almost impervious to the new drugs. Most of the substantial results so far with these expensive drugs have been in treating melanoma and lung cancer.

“ ‘If you have the signature, you should treat with these checkpoint inhibitors,’ Dr. Luis A. Diaz Jr., an associate professor of oncology at Johns Hopkins University and the senior author of the study on the genetic marker, said in an interview, referring to the new drugs.”

‘Immune Checkpoint’ Drugs Show New Promise for Treating Non-Small Cell Lung Cancer

It has become routine practice to prescribe targeted drugs to patients with metastatic non-small cell lung cancer (NSCLC), whose tumors harbor molecular alterations in EGFR, ALK, and ROS. However, the majority of patients with NSCLC have no targetable mutations and lack good treatment options. Enter immunotherapy drugs, specifically ‘immune checkpoint blockade antibodies,’ to which many refer simply as ‘anti-PD-1 drugs,’ or simply ‘PD-1 drugs.’ In this post, I provide some updates on the efficacy of anti-PD-1 and anti-PD-L1 drugs in lung cancer. Continue reading…

Immune Checkpoint Inhibitors in Melanoma: New Directions

The drugs pembrolizumab (Keytruda) and nivolumab (Opdivo) were approved by the U.S. Food and Drug Administration (FDA) in 2014 and 2015, respectively. These two competing blockbuster drugs are already changing the outlook in metastatic melanoma, previously considered to be a fatal disease. Known as ‘immune checkpoint inhibitors,’ they work by releasing ‘brakes’ on a patient’s own immune system, freeing it to attack tumors. In the wake of their success, researchers are now taking immune checkpoint inhibition in new directions. Continue reading…

Test May Show Merck Melanoma Drug's Success in Lung Cancer

“A simple protein test can help identify lung cancer patients who are likely to respond to Merck & Co.’s melanoma drug Keytruda, a trial found.

“Based on the findings, Merck has applied for U.S. Food and Drug Administration approval for the drug in lung cancer patients who have failed other therapies, Merck research chief Roger Perlmutter said in an interview. Keytruda is already approved for treating advanced melanoma.

“In the trial of 495 advanced lung cancer patients treated with Keytruda, researchers tested patients’ tumors for the presence of a protein that tumor cells can use to switch off an immune system response to the cancer.

“People with high levels of the protein, called PD-L1, were far more likely to experience substantial tumor shrinkage after being treated with Merck’s drug than those who had lower levels of the protein, according to results being presented Sunday at the American Association for Cancer Research meeting in Philadelphia.

“The result ‘is very compelling,’ said Roy Herbst, chief of medical oncology at Yale Cancer Center, which participated in the Merck trial. ‘This could tell us who should get this drug and who shouldn’t.’ ”