“AstraZeneca’s immunotherapy drug Imfinzi cut the risk of death in patients with mid-stage lung cancer by nearly a third in a closely watched clinical study, reinforcing the case for using the drug in earlier disease.
“The encouraging overall survival data boosts prospects for a medicine that was approved this week in Europe and has already had a promising U.S. commercial launch, based on its ability to slow disease progression.”
“Immunotherapies targeting PD-1 and PD-L1 have become standards-of-care across all lines of therapy for patients with metastatic non-small cell lung cancer (NSCLC) who do not have targetable driver mutations. Furthermore, the PD-L1 inhibitor durvalumab was recently approved as consolidation therapy after chemoradiation in locally advanced NSCLC. Based on the improved outcomes seen with these agents in advanced NSCLC, they are now being evaluated in early stage NSCLC where effective therapies are needed, as many patients (particularly those beyond stage IB) relapse after surgery, despite neoadjuvant/adjuvant chemotherapy.”
Drugs that activate the immune system to attack cancer in a process known as immune checkpoint blockade (ICB) are a focus of intense investigation. A number of them are already approved by the U.S. Food and Drug Administration (FDA) for various cancers; namely, the anti-CTLA4 antibody ipilimumab (Yervoy), two anti-PD-1 antibodies: pembrolizumab (Keytruda) and nivolumab (Opdivo), and three anti-PD-L1 drugs: atezolizumab (Tecentriq), avelumab (Bavencio) and durvalumab (Imfinzi). These ICB drugs have the potential to induce durable cancer regressions, but the majority of cancer patients just do not respond to them at all.
Biomarkers, signature molecules in the blood or other tissue, can sometimes be used to predict a patient’s response to a given treatment. But no reliable biomarkers exist for ICB, and this is a serious concern. Patients who may really benefit from ICB could be overlooked, and patients who are not likely to respond may receive useless (and very expensive) ICB treatment.
Most potential response predictors that have already been identified are not yet useful for one or all of the following reasons: they are not extensively validated, their significance is still uncertain and may differ from one cancer (or even one patient) to another, or they are technically challenging for routine use. These markers are addressed below. Continue reading…
“The U.S. Food and Drug Administration today approved Imfinzi (durvalumab) for the treatment of patients with stage III non-small cell lung cancer (NSCLC) whose tumors are not able to be surgically removed (unresectable) and whose cancer has not progressed after treatment with chemotherapy and radiation (chemoradiation).”
“Although modern immunotherapy has yet to have a breakthrough in prostate cancer to the degree it has had in lung cancer or urothelial carcinoma, combinations with anti–PD-1/PD-L1 agents are beginning to show promise for these patients in clinical trials.
“Currently ongoing is a phase II trial of durvalumab (Imfinzi) in combination with the PARP inhibitor olaparib (Lynparza) in patients with metastatic castration-resistant prostate cancer (mCRPC; NCT02484404). Investigators note that previous data have suggested that 25% to 30% of sporadic mCRPC has DNA-repair pathway defects. Results thus far have demonstrated that the synergy of durvalumab and olaparib proves that the combination may be a viable option for patients with mCRPC who are heavily pretreated. The trial is still accruing.”
“AstraZeneca and MedImmune, its global biologics research and development arm, today announced that the US Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for Imfinzi (durvalumab) for the treatment of patients with locally advanced (Stage III) unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed following platinum-based chemoradiation therapy. The FDA has granted Imfinzi Priority Review status.”
“The European Society for Medical Oncology (ESMO) 2017 Congress is just around the corner, and we can already say with confidence that there will be many provocative presentations, including several that are poised to change practice. At this point, we can only rely on the abstracts and press releases for several of these, but here are my early impressions on the top five presentations in lung cancer for ESMO 2017.”
“AstraZeneca Plc plunged by a record after suffering a setback to its next-generation cancer medicine, hurting Chief Executive Officer Pascal Soriot’s ambition to join the league of the world’s five largest drugmakers.
“A combination of two immuno-therapies — part of a new class of drugs that activate the body’s defense system to attack tumors — failed to do better than chemotherapy in checking the growth of lung tumors in some patients in the study dubbed Mystic, the U.K. drugmaker said in a statement on Thursday. The drugs were poised to generate more than $7 billion in sales by 2022, according to analysts’ estimates compiled by Bloomberg, and would have made the Imfinzi treatment into Astra’s best-selling medicine.”
Last month, the annual American Society of Clinical Oncology (ASCO) meeting took place in Chicago. Thousands of oncologists, patients, and journalists gathered to learn about the most recent developments in cancer research and treatment. Here are some breast cancer highlights from the meeting:
Triple negative breast cancer (TNBC) is considered more responsive to treatment with immune checkpoint drugs than any other type of breast cancer. So far, these drugs have primarily been explored in metastatic TNBC, in combination with chemotherapy. The combination of “anti-PD-L1” and “anti-PD-1” immune checkpoint drugs with chemotherapy has now been examined in early-stage TNBC, in which a breast tumor can be surgically removed after neoadjuvant chemotherapy. Continue reading…