Bristol-Myers’ Tarnished Checkpoint Star Opdivo Beats out Yervoy in Surprise PhIII


“Bristol-Myers got a much-needed boost with the earlier-than-expected news that Opdivo beat out Yervoy in a Phase III study focused on a particular niche for adjuvant melanoma therapy. And an analyst who’s been following the data says it could be worth a billion dollars in added annual sales.

“The big biotech says an interim analysis of Checkmate-238 provided researchers with proof that the PD-1 drug outperformed Yervoy, Bristol-Myers’ CTLA-4 drug, among advanced Stage IIIb or IV patients, cutting the recurrence rate for those who have undergone surgery. There are no bottom line numbers in the statement, but Bristol-Myers says they’ll be able to release data at an upcoming conference to show that Opdivo provided a significantly lower risk of disease recurrence.”

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OPTiM Follow-up Shows Improved CR Rate With T-VEC in Melanoma

“A retrospective analysis of the phase III OPTiM study found that treatment with talimogene laherparepvec (T-VEC; Imlygic) resulted in complete responses (CR) in 17% of patients seen in all stages of melanoma. Median time to achieve a CR was 8.6 (6.0–13.6) months. A high proportion of response occurred in patients with early-stage disease and lower tumor burden, according to study authors.

“In OPTiM, a phase III trial in 436 patients with unresected stage IIIB to IV melanoma, T-VEC improved durable response rates from 2.1% to 16.3% versus subcutaneous GM-CSF. Overall response rates (ORR) for T-VEC and GM-CSF were 26.4% and 5.7%, respectively. Median overall survival (OS) was 23.3 months with T-VEC and 18.9 months with GM-CSF (HR, 0.79; 95% CI, 0.62–1.00; P = .051).”

Amgen Receives CHMP Positive Opinion For IMLYGIC™ (Talimogene Laherparepvec)

“Amgen AMGN, +1.94% today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion recommending that IMLYGIC™ (talimogene laherparepvec) be granted approval for the treatment of adults with unresectable melanoma that is regionally or distantly metastatic (Stage IIIB, IIIC and IVM1a) with no bone, brain, lung or other visceral disease. If approved by the European Commission, IMLYGIC would be the first in a class of novel agents known as oncolytic immunotherapies.

“IMLYGIC, administered via intralesional injection, is designed to cause the death of tumor cells and to initiate an anti-tumor immune response.”

No Benefit of Adding Gefitinib to Platinum-Based Doublet in EGFR-Mutant NSCLC After Progression on First-Line Gefitinib

“In a phase III IMPRESS trial reported in The Lancet Oncology, Soria et al found no progression-free survival benefit of adding gefitinib (Iressa) to platinum-based doublet chemotherapy in patients with advanced EGFR-mutant non–small cell lung cancer (NSCLC) who had acquired resistance to first-line gefitinib.

“In the double-blind trial, 265 chemotherapy-naive patients from 11 countries who had stage IIIB to IV EGFR-mutant disease and disease control with first-line gefitinib and recent disease progression took part. They were randomly assigned between March 2012 and December 2013 to receive cisplatin 75 mg/m2 plus pemetrexed (Alimta) 500 mg/m2 on the first day of a maximum of six chemotherapy cycles plus either daily gefitinib 250 mg (n = 133) or placebo (n = 132) continued until disease progression or discontinuation for other reasons…

“The investigators concluded: ‘Continuation of gefitinib after radiological disease progression on first-line gefitinib did not prolong progression-free survival in patients who received platinum-based doublet chemotherapy as subsequent line of treatment. Platinum-based doublet chemotherapy remains the standard of care in this setting.’ ”

Afatinib Improves Progression-Free Survival vs Erlotinib in Second-Line Treatment of Advanced Squamous Cell Carcinoma of the Lung

“In the phase III LUX-Lung 8 trial reported in The Lancet Oncology, Soria et al found that the irreversible ErbB-family inhibitor afatinib (Gilotrif) significantly improved progression-free and overall survival vs the EGFR tyrosine kinase inhibitor erlotinib as second-line treatment in patients with stage IIIB or IV squamous cell carcinoma of the lung who had disease progression after four or more cycles of platinum-based chemotherapy.

“In this open-label trial, 795 patients from 23 countries were randomly assigned between March 2012 and January 2014 to receive afatinib at 40 mg/d (n =398) or erlotinib at 150 mg/d (n = 397). The primary endpoint was progression-free survival on independent central review in the intent-to-treat population…

“The investigators concluded: ‘The significant improvements in progression-free survival and overall survival with afatinib compared with erlotinib, along with a manageable safety profile and the convenience of oral administration suggest that afatinib could be an additional option for the treatment of patients with squamous cell carcinoma of the lung.’ “

Surgery May Boost Survival in Certain Advanced Lung Cancers

“Certain patients with lung cancer that’s spread throughout the chest could live longer by undergoing surgery to remove diseased lung tissue, instead of receiving only chemotherapy and radiation, new research suggests.

“The study was based on a review of data on more than 9,000 patients with stage 3b non-small cell lung cancer—tumors that have spread to lymph nodes or other organs in the chest. The researchers found that those who underwent a combination of surgery, chemotherapy and radiation treatment lived an average of almost 10 months longer than those receiving chemo and radiation alone.

“Typically, surgery isn’t offered to patients with such advanced cases of non-small cell lung cancer, physicians said, and some may also be too ill to undergo the procedure.

“However, ‘we think our study reignites a question that was initially asked in the 1980s and 1990s but has become more or less dormant in lung cancer circles,’ said study author Dr. Varun Puri, an assistant professor of surgery in the division of cardiothoracic surgery at Washington University School of Medicine in St. Louis.

“According to Puri, the take-home message from the study is that ‘we should not consider all stage 3b non-small lung cancer patients as being eligible for only chemo-radiation therapy. An experienced thoracic surgeon should evaluate these patients and decide [if surgery is also an option] on a case-by-case basis.’ “

Nedaplatin plus Docetaxel 'New Standard of Treatment' for Advanced Squamous Lung Carcinoma

“Nedaplatin plus docetaxel conferred significantly improved OS rates compared with cisplatin plus docetaxel in patients with advanced or relapsed squamous cell lung carcinoma, according to the results of a phase 3 study presented at the ASCO Annual Meeting.

“ ‘Limited progress has been made for the treatment of advanced squamous cell lung cancer compared with non-squamous non–small cell lung cancer,’ Takehito Shukuya, MD, of the department of respiratory medicine at Juntendo University in Tokyo, said during a presentation. ‘Cisplatin plus docetaxel is the current standard of care in patients with advanced squamous cell lung cancer.’ “

“Nedaplatin (Aqupla, Shionogi Co) is a second-generation platinum compound that produces a reduced rate of certain adverse events — including nausea, vomiting and nephrotoxicity — compared with cisplatin. A previous phase 2 study of nedaplatin plus docetaxel demonstrated encouraging outcomes with acceptable toxicity for patients with advanced squamous cell lung carcinoma, according to study background.”

Consideration of EGFR Status in NSCLC Varies Among International Community

“The International Association for the Study of Lung Cancer (IASLC) guidelines recommend that patients with non-small cell lung cancer (NSCLC) get tested for the epidermal growth factor receptor (EGFR) mutation prior to treatment, but this doesn’t always happen, a new study concludes. This was first reported at the European Lung Cancer Conference (ELCC) in Geneva, Switzerland, April 2015, and was published online in the April 2015 issue of Annals of Oncology. IASLC does not recommend this testing for squamous cell carcinoma (SCC), only NSCLC.

“James Spicer, MRCP, PhD, a medical oncologist at King’s College London at Guy’s Hospital, London, and colleagues took a look at hospitals globally to learn how and when they were testing for the EGFR gene in patients with stage IIIb/IV lung cancer.

“To find out what was happening in hospitals worldwide, the investigators conducted an online survey of 562 oncologists in 10 countries (Canada, France, Germany, Italy, Japan, South Korea, Spain, Taiwan, United Kingdom, and the United States) between December 2014 and January 2015. The researchers in London discovered that the EGFR test was being requested approximately 81% of the time, but first-line treatment, for some patients, was underway before the results came in. This occurred for several reasons; in some cases, the wait time for results was too long for the patients with advanced cancer who needed immediate treatment. Other times, tissue was not available.”

T-VEC plus Ipilimumab Appears Safe, Effective for Unresected Melanoma

“Talimogene laherparepvec combined with ipilimumab demonstrated tolerability at the planned doses without dose-limiting toxicities in patients with unresected, stage IIIB to IV melanoma, according to study results presented at the HemOnc Today Melanoma and Cutaneous Malignancies meeting in New York.

“The combination also demonstrated higher overall and complete response rates than typical for either agent alone, results showed.

“Talimogene laherparepvec (T-VEC, Amgen) — a systemically active oncolytic immunotherapy derived from herpes simplex virus type 1 — yielded a higher durable response (≥ 6 months) than granulocyte-macrophage colony-stimulating factor (GM-CSF) in a phase 3 melanoma trial, according to study background.

“Igor Puzanov, MD, MSCI, FACP, of the division of hematology-oncology at Vanderbilt University Medical Center, and colleagues sought to evaluate the safety and efficacy of T-VEC in combination with ipilimumab (Yervoy, Bristol-Myers Squibb).”