(Bristol-Myers) Oct 12, 2018 - Bristol-Myers Squibb Company today announced topline results from the Phase 3 CheckMate -331 study evaluating Opdivo (nivolumab) versus the current standard of care, topotecan or amrubicin (where approved), in patients with small cell lung cancer (SCLC) who relapsed following platinum-based chemotherapy. The study did not meet its primary endpoint of overall survival (OS) with Opdivo versus chemotherapy. The safety profile of Opdivo in this trial was consistent with that observed in previously reported monotherapy studies involving patients with SCLC.

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H. Jack West, MD (Posted: October 12, 2018)

Disappointing result, especially since treatment with either topotecan or amrubicin in relapsed SCLC represents a very low bar for any competing idea. This represents an area where the standard of care is particularly unimpressive, so for nivolumab to have failed to beat chemotherapy here represents a major disappointment. With the positive OS data seen with IMpower133 that added atezolizumab to standard first line chemotherapy in NSCLC, we are likely to see immunotherapy move overwhelmingly into the first line setting, but here nivolumab suffers in comparison by failing to beat even a weak competitor.

(IASLC) Oct 10, 2018 - Patients with metastatic NSCLC receiving treatment at academic centers (ACs) have an increased 2-year survival compared to patients treated at community-based centers (CCs). An overall histology-dependent survival was also noted in patients with adenocarcinoma verses squamous cell carcinoma and varied by treatment facility. Lung cancer is the most common cancer and the leading cause of cancer-related death worldwide. There are two major types of lung cancer, small cell and non-small cell lung cancer (NSCLC). Roughly 85% of diagnosed lung cancers are NSCLC with about 40% of NSCLC patients presenting with stage IV metastatic disease. Adenocarcinoma histological subtype accounts for 40% of all NSCLC and squamous cell carcinoma histological subtype accounts for roughly 30%.

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H. Jack West, MD (Posted: October 11, 2018)

Notably, these results that are coming from academic centers may stem from them having more expertise, more access to newer agents and clinical trials, or some combination of these issues, but selection bias due to differences in the patient populations is always an issue with retrospective database analyses. The patients treated at academic centers have a better performance status and socioeconomic support, including people, funds, and other resources that also contribute to better outcomes. This isn't to say that selection bias explains the difference, but there are many contributing factors, and there is no question that the patients who receive care at academic centers are not the same population as those who don't, and these differences skew toward better results in these patients.

(Pfizer) Sept 27, 2018 - Pfizer Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved VIZIMPRO® [vih-ZIM-pro] (dacomitinib), a kinase inhibitor for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test. “Improving outcomes for patients is the central focus of why we develop and deliver new medicines. VIZIMPRO is yet another example of Pfizer’s commitment to providing more options in lung cancer where there is great unmet need,” said Andy Schmeltz, Global President, Pfizer Oncology. “With today’s approval, Pfizer has medicines that target three unique lung cancer biomarkers, marking real progress for patients which has been achieved through a diverse and persistent drug development approach.”

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H. Jack West, MD (Posted: September 28, 2018)

Dacomitinib clearly has activity for EGFR mutation-positive NSCLC, but I suspect this approval will have very little impact in the already crowded first line landscape. Dacomitinib is clearly superior to gefitinib in both PFS and even OS based on the ARCHER-1050 trial. Osimertinib, however, is now the emerging first line standard of care and is likely to remain so for several reasons: 1) Dacomitinib toxicity is quite challenging, with 66.5% of patients assigned to daco on ARCHER-1050 requiring dose reduction and very high rates of misery-inducing side effects. Osimertinib is generally very well tolerated. 2) ARCHER-1050 excluded patients with known brain metastases, while osimertinib has consistently impressive CNS activity, with a CNS RR of 91% in the FLAURA trial among patients who started with baseline measurable brain mets. CNS control for existing or potential future brain mets is an increasingly significant factor when one option is clearly superior in this regard. 3) Though Pfizer may argue that starting with daco preserves the potential for osimertinib later, only a very small minority of the patients on ARCHER-1050 actually got osimertinib, so we should not presume this will be trivially easy to accomplish for the majority of patients. PFS for first line osi vs. daco is more than 3 months longer with osi. 4) At least among lung cancer experts, but I believe among oncologists in general, Pfizer has had very little presence, while AZ has been heavily marketing and running educational programs. This is a minor factor next to the data, but it is just one more obstacle for Pfizer to overcome. It has shown no interest in developing relationships with oncologists or in cultivating a sense of corporate citizenship by sponsoring educational activities or supporting other valuable programs in the oncology community over many years.