July 3, 2019 - Episode 1

FDA Approvals in Myeloma, NETs, and of a Biosimilar, Priority Review in Ovarian Cancer, and More


FDA approvals in multiple myeloma, neuroendocrine tumors, and of a biosimilar, a priority review designation in ovarian cancer, a partial clinical hold lifted in multiple myeloma, and encouraging findings in a lung cancer trial.

Welcome to OncLive News Network! I’m Kristi Rosa.

The FDA has approved the combination of daratumumab with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation.

The approval, which was granted through the agency's Real-Time Oncology Review pilot program, is based on findings from the phase III MAIA trial, in which the daratumumab regimen reduced the risk of disease progression or death by 44% in this patient population versus lenalidomide/dexamethasone alone.

In the open-label, multicenter, phase III MAIA trial, 737 newly diagnosed patients with multiple myeloma who were ineligible for high-dose chemotherapy and ASCT aged 45 to 90 years old.

At a median follow-up of 28 months, results showed that the median progression-free survival for DRd had not yet been reached versus 31.9 months for patients who received Rd alone.

Moreover, DRd led to deeper responses versus Rd alone, including higher rates of a complete response or better at 48% versus 25%. The overall response rate was also higher with the triplet regimen, at 93% versus 81%, respectively.


The FDA approved a prefilled syringe for lanreotide, which has been designed to enable healthcare providers to more easily administer the injection easier, for the treatment of adults with unresectable, well or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors.

The indications for the treatment remain the same as that of the previously approved prefilled syringe. It is also indicated for use in the long-term treatment of patients with acromegaly who inadequately respond to surgery and/or radiotherapy as well as for those who are not candidates for surgery and/or radiotherapy.

The prefilled syringe can be used as a means to improve progression-free survival and in adult patients with carcinoid syndrome to reduce the frequency of short-acting somatostatin analog rescue therapy.

In an effort to understand the way the syringe was being used in clinical practice as well as identify ways in which features of the device might be improved, investigators launched 5 different, but complementary, studies in partnership with patients, their caregivers, nurses, and other healthcare professionals.

The feedback from these studies informed the redesign for the syringe, which was envisioned to increase the grip on the product, and thus, make it easier to administer the injection.

Lanreotide was originally approved for the treatment of patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic GEP-NETs in December 2014.


The FDA approved the bevacizumab biosimilar PF-06439535, known by the trade name Zirabev, for the treatment of patients with metastatic carcinoma of the colon or rectum; unresectable advanced, metastatic, or recurrent non—small cell lung cancer; advanced and/or metastatic renal cell cancer, and persistent recurrent or metastatic carcinoma of the cervix.

The approval is based on findings from a comprehensive data package, which demonstrated biosimilarity of PF-06439535 to reference bevacizumab. This includes results from the REFLECTIONS B7391003 trial, which showed clinical equivalence and found no clinically meaningful differences between PF-06439535 and bevacizumab in patients with advanced non-squamous NSCLC.

PF-06439535 is a monoclonal antibody biosimilar of reference bevacizumab that works by inhibiting angiogenesis by specifically recognizing and binding to the VEGF protein. As part of the REFLECTIONS clinical trial program, PF-06439535 has been studied in nearly 400 patients to date.

In February 2019, the European Commission previously approved PF-06439535 for indications in colorectal, breast, lung, kidney, and cervical cancer.


The FDA has granted a priority review designation to a supplemental biologics license application for the PARP inhibitor niraparib for the treatment of patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with 3 or more prior chemotherapy regimens, and who have either a BRCA mutation or have homologous recombination deficiency and progressed at least 6 months after their last platinum-based chemotherapy.

The designation is based on findings from the QUADRA study, in which the overall response rate was 28% in the primary efficacy population of patients who had HRD and who received at least 3 prior lines of therapy.

Results of a posthoc analysis of QUADRA from the BRCA-mutant cohort, which comprised patients who were also PARP inhibitor—naïve, showed that the ORR was 29% in this subgroup. The response rates were similar between those with germline and somatic BRCA mutations, which were 25% versus 33%.

The FDA must make a decision on the sBLA by October 24, 2019.


In multiple myeloma, the FDA has lifted a partial clinical hold that was placed on the phase III CANOVA study, which is examining venetoclax in combination with pomalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma that harbors 11;14 transclocation.

The lift on the partial hold is based on an agreement on revisions to the CANOVA study protocol, which includes new risk mitigation measures, protocol-specified guidelines, and fully updated criteria.

However, the lift does not apply to other clinical trials evaluating venetoclax in multiple myeloma while next steps continue to be addressed with the FDA.

The agency previously placed a partial clinical hold on all studies that are evaluating the BCL-2 inhibitor in patients with multiple myeloma. In the phase III BELLINI trial of venetoclax with bortezomib and dexamethasone versus placebo in patients with relapsed/refractory multiple myeloma, a higher proportion of deaths was observed in the venetoclax arm compared with the control arm of the trial, and 45 patients died due to progressive disease.


The combination of durvalumab with standard etoposide and platinum-based chemotherapy demonstrated a statistically significant and clinically meaningful improvement in overall survival compared with standard chemotherapy alone as a first-line treatment in patients with extensive-stage small cell lung cancer, meeting the primary endpoint of the phase III CASPIAN trial.

The safety and tolerability findings of the immunotherapy/chemotherapy combination were consistent with the safety profile of each agent alone, and full findings of the study will be presented at an upcoming medical meeting.

In the international, multicenter, open-label, CASPIAN study, 988 treatment-naïve patients with extensive-stage SCLC were randomized 1 to 1 to 1 to durvalumab plus etoposide and either cisplatin or carboplatin, durvalumab plus the CTLA-4 inhibitor tremelimumab and chemotherapy, or chemotherapy alone.

Durvalumab is currently approved by the FDA for the treatment of patients with locally advanced, unresectable stage III non—small cell lung cancer who have not progressed following chemoradiotherapy.

This week, we sat down with Dr Naval G. Daver, of The University of Texas MD Anderson Cancer Center, to discuss how to decide a frontline treatment for patients with newly diagnosed acute myeloid leukemia.

That’s all for today.

Thank you for watching OncLive News Network! I’m Kristi Rosa.