Stay informed on the latest news within oncology drug development. Subscribe to our newsletter to keep up to date with last month's science, industry and regulatory oncology highlights.
Enjoy reading! - The SMS-oncology team
News and publications
Caring for cancer patients during the COVID-19 pandemic: The worldwide public health emergency caused by the coronavirus disease (COVID-19) pandemic poses challenges to the clinical treatment of cancer patients. In The Oncologist, Al-Shamsi et al. offer several practical recommendations for cancer care management. Hospital visits should be reduced as much as possible, by delaying treatment for low-risk cancers, switching from intravenous to oral chemotherapy agents for outpatient treatment, or supporting patients remotely using telemedicine technologies. In cases where onsite treatment may not be responsibly avoided, the risk of infection should be minimized for patients and healthcare practitioners. Recommendations include extensive viral screenings, minimizing staff overlap between COVID-19 and other treatment areas, strict hygiene measures, and use of protection equipment. Additional psychological support may be given to patients following diagnosis to help cope with uncertain risks and social isolation, and clear communication is required to guide patient decisions regarding new/modified treatments.
- Johnson&Johnson and Fate Therapeutics enter pact to co-develop allogeneic “off-the-shelf" cell therapies for blood cancers and solid tumors. Per deal terms, J&J will buy $50 million worth of Fate shares at $31/piece. The pact reflects the latest focus of J&J on allogeneic cell therapies, which could be cheaper than the "autologous" T-cell chimeric antigen receptor approved therapies that struggle commercially.
- iTheos Therapeutics closes series B2 financing worth $125 million that can be used for advancing clinical development of next-generation cancer immunotherapies targeting A2A adenosine receptors and TIGIT domains.
- Servier acquires Symphogen, a biotech company that specializes in antibody-based therapies for cancer. Neither party disclosed financial details of the deal, however a straight transaction where Servier bought all of Symphogen’s shares took place.
The Committee for Medical Products for Human Use (CHMP) adopted a positive opinion for:
- Glasdegib (Daurismo, Pfizer Europe) in combination with low-dose cytarabine for the treatment of newly diagnosed de novo or secondary acute myeloid leukemia in adult patients who are not candidates for standard induction chemotherapy.
- Luspatercept (Reblozyl, Celgene Europe) for the treatment of adult patients with transfusion-dependent anemia due to myelodysplastic syndromes (MDS) with ring sideroblasts, who had an unsatisfactory response to/are ineligible for erythropoietin-based therapy, and for the treatment of adult patients with transfusion-dependent anemia associated with beta-thalassemia.
- Cabazitaxel (Accord Healthcare) as a hybrid medicine combined with prednisone/prednisolone for the treatment of hormone refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen.
Extensions of indications:
- Encorafenib (Braftovi, Pierre Fabre Medicament) in combination with cetuximab for the treatment of BRAFV600E-mutant metastatic colorectal cancer (CRC) after prior therapy.
- Carmustine (Obvius Investment) as conditioning treatment prior to autologous hematopoietic progenitor cell transplantation (HPCT) in malignant hematological diseases (Hodgkin’s disease/Non-Hodgkin’s lymphoma).
The FDA granted approval for:
- Niraparib (Zejula, GSK) as the only once-daily poly (ADP-ribose) polymerase inhibitor in first-line monotherapy maintenance treatment for women with platinum-responsive advanced ovarian cancer regardless of biomarker status. Approval was based on the Phase III PRIMA trial, whose results reported a median progression-free survival (PFS) of 13.8 vs 8.2 months in patients receiving niraparib vs placebo.
- Sacituzumab govitecan-hziy (Trodelvy, Immunomedics) or adult patients with metastatic triple-negative breast cancer who received at least two prior therapies for metastatic disease. Approval was based on the single-arm Phase I/II IMMU-132-01 trial, whose results reported a 33.3% overall response rate (ORR) following treatment.
- Ibrutinib (Imbruvica, Pharmacyclics LLC) combined with rituximab by extending its indication to patients with chronic/small lymphocytic leukemia. Approval was based on the Phase III E1912 trial, whose results reported significant improvements in PFS in the ibrutinib and rituximab vs fludarabine, cyclophosphamide, and rituximab arms (median PFS was not reached in either arm).
- Pemigatinib (Pemazyre, Incyte), the first and only drug approved for treatment of adults with previously treated, unresectable, locally advanced/metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 fusion or other rearrangements. Approval was based on the Phase II FIGHT-202 trial, whose results reported a 36% ORR following treatment of these difficult-to-treat patients.
- Tucatinib (Tukysa, Seattle Genetics) combined with trastuzumab and capecitabine for patients with advanced unresectable/metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer who received ≥1 prior anti-HER2-based regimens in the metastatic setting. Approval was based on the Phase II HER2CLIMB trial, whose results reported a 46% and, respectively, 34% reduction in the risk of cancer progression/death and, respectively, of death alone for patients receiving the triple treatment vs trastuzumab plus capecitabine. This is the first HER2 tyrosine kinase inhibitor in combination to improve outcomes of patients with metastatic HER2-cancer.
- Mitomycin (Jelmyto, UroGen Pharma), the first and only non-surgical treatment for low-grade upper tract urothelial cancer. Approval was based on the Phase III OLYMPUS trial, whose results reported a 58% complete response rate in the overall population and in the sub-population of patients deemed not capable of surgical removal at diagnosis.
- Selumetinib (Koselugo, AstraZeneca), the first medicine approved for pediatric patients (≥2 years) with neurofibromatosis type 1 who have symptomatic, inoperable plexiform neurofibromas. Approval was based on the single-arm Phase I/II SPRINT trial, whose results reported an ORR of 66% in these patients.
- Encorafenib (Braftovi, Pfizer) in combination with cetuximab as the first approved regimen for treatment of BRAFV600E-mutant metastatic CRC after prior therapy. Approval was based on the Phase III BEACON trial results, which reported a median overall survival of 8.4 vs 5.4 months for the encorafenib plus cetuximab vs irinotecan plus cetuximab.
- Luspatercept-aamt (Reblozyl, Celgene Corporation) for the treatment of anemia failing an erythropoiesis-stimulating agent and requiring ≥2 red blood cell (RBC) units over 8 weeks in adult patients with low- to intermediate-risk MDS or with myelodysplastic/myeloproliferative neoplasm, with ring sideroblasts. Approval was based on the Phase III MEDALIST trial, whose results reported a 37.9% vs 13.2% of RBC-transfusion independent patients in the luspatercept-aamt vs placebo groups.
- Cobas HPV test (Roche), the first test for quantitative identification of women at risk for cervical cancer, to use on the automated, high-throughput Cobas 6800/8800 Systems.
The FDA also granted breakthrough therapy designation to the following drugs/devices to advance their development:
- Mobocertinib (TAK-788, Takeda), for treatment of patients with non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations.
- Avelumab (Bavencio, Merck and Pfizer), for first-line maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma.
The FDA released the final guidance (13Apr2020) to broaden labeling for precision oncology. A definition of specific groups of oncology products was provided, as having “the same approved indications, including molecular alteration(s), for which a companion diagnostic could potentially be labeled”. The guidance also explained that broader labeling for companion diagnostics will facilitate the clinical development/use of future oncology treatments, but should be performed with caution in assessing differences between diagnostics, to ensure that their use across a group of products is clinically appropriate.
The American Society of Clinical Oncology (ASCO) released on 09Apr2020 recommendations to support the oncology community in the process of allocating scarce healthcare resources during the COVID-19 pandemic. ASCO’s recommendations assert:
- Institutions should develop a consistent prioritization and allocation policy before allocation becomes necessary. Decisions should be made at an institution level, rather than at patient bedside.
- Resource allocation should be based on maximizing health benefits. Rationing for lifesaving critical care resources should not use assessments about the perceived quality of a patient’s life or perceptions about a patient’s social worth.
- Oncologists should work with their institutions on how to most efficiently utilize scarce resources for care and support of cancer patients.
- Oncologists, with the support of healthcare institutions, should communicate allocation plans and decisions to their patients with compassion and honesty.
- Oncologists should engage in advance care planning discussions with their patients and carefully document patient requests for goals of care, particularly end of life care.