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A
ABVD
An abbreviation for a chemotherapy combination used in the front-line treatment of Hodgkin lymphoma. It includes the
drugs doxorubicin hydrochloride (Adriamycin), bleomycin, vinblastine, and dacarbazine.
Affinity
Measurement of binding strength between two biological molecules.
Allogeneic stem cell transplant
A procedure in which blood-forming stem cells (cells from which all blood cells develop) are drawn from a donor whose
tissue type closely matches the patient's. This can be from a related donor or an unrelated donor.
Anaplastic large cell lymphoma (ALCL)
Anaplastic large cell lymphoma (ALCL) is a type of T-cell non-Hodgkin lymphoma. Most ALCL cases fall into one of
two distinct forms: systemic ALCL, involving lymph nodes or extranodal sites; or primary cutaneous ALCL, involving
skin nodules. ALCL cancer cells express a marker called CD30 on the surface.
Antibody
A component of the body’s immune system. An antibody is a Y-shaped protein that binds specifically to an antigen (foreign substance)
and marks it for destruction and/or removal. Antibodies can work in several ways, depending on the nature of the antigen. Some antibodies
destroy antigens directly while others make it easier for white blood cells to destroy the antigen.
Antibody-drug conjugate (ADC)
An antibody linked to a cytotoxic drug for the purpose of specific delivery to target cells.
Antigen
A substance that causes the immune system to make a specific immune response.
Antitumor
Stopping abnormal cell growth.
Apoptosis
Also known as programmed cell death or cell suicide, it is the natural process by which cells die in order to prevent the
spread of disease. In diseases such as cancer, this cell death mechanism does not function properly and cancer cells
are allowed to proliferate. Apoptosis can be brought about by some drugs used to treat cancer.
Auristatins
A highly potent, cell-killing class of drugs derived from the natural product Dolabella auricularia. See also MMAE and
MMAF.
Autoimmune disease
A condition in which the body recognizes its own tissues as foreign and directs an immune response against them.
Autologous stem cell transplant
A procedure in which blood-forming stem cells (cells from which all blood cells develop) are removed, stored, and later
given back to the same person.
B
B-cells
B-cells (B-lymphocytes) are part of the immune system. They originate in the bone marrow and mature into plasma
cells that secrete antibodies, the proteins that recognize and attach to foreign substances known as antigens. B-cells
are an important part of the immune system and play a key role in the development of certain forms of cancer and
autoimmune disease.
Biologic
A substance that is made from a living organism or its products and is used in the prevention, diagnosis, or treatment
of cancer and other diseases. Antibodies are biologics. Also called biological agent and biological drug.
Biologics License Application (BLA)
A submission to the Food and Drug Administration for approval to market a biologic. Issuance of a biologics license is
a determination that the product, the manufacturing process, and the manufacturing facilities meet applicable
requirements to ensure the continued safety, purity and potency of the product.
Bone marrow
The soft, spongy tissue in the hollow middle of flat bones of the body where new blood cells are made.
C
Cancer
A group of diseases characterized by abnormal cells that grow and spread uncontrollably. A mass, or collection, of
cancer cells called a malignant tumor frequently grows rapidly, invading and destroying nearby tissue. Cancer cells
often travel to other body parts where they grow and replace normal tissue. This process, called metastasis, occurs as
the cancer cells get into the bloodstream or lymph vessels.
Cancer cell
A cell that divides and reproduces abnormally and can spread throughout the body, crowding out normal cells and
tissue.
Carcinoma
Cancer that begins in the skin or in tissues that line or cover internal organs.
Chemotherapeutic
A drug administered to stop the growth of or to kill cancer cells.
Chemotherapy
Treatment with drugs that kill cancer.
Chimeric
An antibody comprised of both mouse and human antibody components, usually a 30/70 percent split, respectively.
CHOP
An abbreviation for a chemotherapy combination that is used to treat non-Hodgkin lymphoma and is being studied in
the treatment of other types of cancer. It includes the drugs cyclophosphamide, doxorubicin hydrochloride
(hydroxydaunorubicin), vincristine (Oncovin), and prednisone.
Cleavable
Capable of being split or separated.
Clinical trials
Drug testing in humans to assess safety, side effects and efficacy.
Complete remission / Complete response
The disappearance of all detectable signs of cancer, though not necessarily that the cancer has been cured.
CT Scan
A series of detailed pictures of areas inside the body taken from different angles. The pictures are created by a
computer linked to an x-ray machine. Also called CAT scan, computed tomography scan, computerized axial
tomography scan, and computerized tomography.
Cytotoxic
Toxic to cells; cell-killing.
D
De novo
In cancer, the first occurrence of cancer in the body.
Diffuse large B-cell lymphoma (DLBCL)
A type of B-cell non-Hodgkin lymphoma (cancer of the immune system) that is usually aggressive (fast-growing). It is
the most common type of non-Hodgkin lymphoma.
Double-blind
A clinical trial design in which neither the participating individuals nor the study medical staff knows which participants
are receiving the experimental drug and which are receiving a placebo (or another therapy). Double-blind trials are
thought to produce objective results, since the expectations of the doctor and the participant about the experimental
drug do not affect the outcome.
E
Efficacy
Effectiveness, or the ability of a drug to produce the desired beneficial effect.
Endpoint
Overall outcome that the clinical trial protocol is designed to evaluate. Common endpoints are safety, tolerability,
response or survival.
Enzyme
A protein functioning as a catalyst, speeding up the rate of biochemical reactions.
Evaluable patients
Patients whose response to a treatment can be measured because enough information has been collected.
F
Fast Track
Under the FDA Modernization Act of 1997, the Fast Track Program of the FDA is designed to facilitate the
development and expedite the review of a new drug that is intended for the treatment of a serious or life-threatening
condition, and demonstrates the potential of a drug candidate to address unmet medical needs for such a condition.
Follicular lymphoma
A type of B-cell non-Hodgkin lymphoma (cancer of the immune system) that is usually indolent (slow-growing). The
tumor cells grow as groups to form nodules. There are several subtypes of follicular lymphoma.
Food and Drug Administration (FDA)
An agency in the U.S. federal government whose mission is to protect public health by making sure that food,
cosmetics, and nutritional supplements are safe to use and truthfully labeled. The FDA also makes sure that drugs,
medical devices, and equipment are safe and effective.
H
Half-life
The time required for half the quantity of a drug to be metabolized or eliminated from an organism.
Hazard ratio
A measure of how often a particular event happens in one group compared to how often it happens in another group,
over time. In cancer research, hazard ratios are often used in clinical trials to measure survival at any point in time in a
group of patients who have been given a specific treatment compared to a control group given another treatment or a
placebo. A hazard ratio of one means that there is no difference in survival between the two groups. A hazard ratio of
greater than one or less than one means that survival was better in one of the groups.
Healthy volunteer study
In a clinical trial, a person who does not have the disorder or disease being studied. Healthy volunteers may be used
to evaluate preliminary tolerability, pharmacokinetics and other aspects of a drug prior to being studied in people with
the target disease.
Hematologic malignancy
Cancer of the blood or bone marrow, including leukemia and lymphoma.
Hodgkin lymphoma (Hodgkin disease)
A type of lymphoma that usually begins in the lymph nodes of the neck, axillae and chest. Diagnosis is often aided by
the identification of characteristic tumor cells referred to as Reed-Sternberg cells. A defining attribute of the Reed-
Sternberg cell is its expression of CD30.
Humanized antibody
An antibody that contains over 90 percent human material.
I
ICE
An abbreviation for a chemotherapy combination that is used to treat non-Hodgkin and Hodgkin lymphomas that have
come back and do not respond to other treatments. It includes the drugs ifosfamide, carboplatin, and etoposide.
Immune system
The complex group of organs and cells that defends the body against infections and other diseases.
Immunologic disease
A disease characterized by a dysfunctional immune system. See autoimmune disease.
Immunotherapy
Treatment to boost or restore the ability of the immune system to fight cancer, infections, and other diseases. Agents
used in immunotherapy include monoclonal antibodies, growth factors, and vaccines. These agents may also have a
direct antitumor effect.
Incidence
The number of new cases of a disease that occur in a group of people each year (as opposed to prevalence).
Investigational New Drug (IND)
A submission to the FDA with the data necessary to show that it is reasonable to begin tests of a new drug on humans.
In vitro
Laboratory experiments performed in the laboratory (outside the body), such as in a test tube.
In vivo
Laboratory experiments performed in a living organism. An example is the injection of a substance into a rat to
determine the substance's effect on the animal.
L
Linker / linkage system
The chemical structure connecting an antibody with a cell-killing payload.
Leukemia
Leukemia is a cancer of the bone marrow and blood, characterized by the uncontrolled proliferation of immature blood
cells. The four main types of leukemia are acute myeloid leukemia, acute lymphocytic leukemia, chronic myelogenous
leukemia and chronic lymphocytic leukemia.
Lymphocyte
A type of white blood cell that is made in the bone marrow and is found in the blood and in lymph tissue. The two main
types of lymphocytes are B lymphocytes and T lymphocytes. B lymphocytes make antibodies, and T lymphocytes help
kill tumor cells and help control immune responses.
Lymphoma
Lymphoma is a general term for a group of cancers that originate in the immune system. Lymphoma results when a
lymphocyte (a type of blood cell) undergoes a malignant change and accumulates because of exaggerated
multiplication and/or a failure to die. This excess of lymphocytes interferes with the growth of normal blood cells and
creates masses of tumors in lymph nodes. The two main types of lymphoma are Hodgkin lymphoma and non-Hodgkin
lymphoma. Hodgkin lymphoma is marked by the presence of a type of cell called the Reed-Sternberg cell, which
expresses CD30. Non-Hodgkin lymphomas include a large, diverse group of cancers of immune system cells. Non-
Hodgkin lymphomas can be further divided into cancers that have an indolent (slow-growing) course and those that
have an aggressive (fast-growing) course. These subtypes behave and respond to treatment differently.
Lysosome
A sac-like compartment inside a cell that has enzymes that can break down cellular components that need to be
destroyed.
M
Malignant
Cancerous. Malignant tumors can invade and destroy nearby tissue and spread to other parts of the body.
Maximum Tolerated Dose (MTD)
The highest dose of a drug or treatment that does not cause unacceptable side effects. The MTD is determined in
clinical trials by testing increasing doses on different groups of people until the highest dose with acceptable side
effects is found.
Median survival
The time point at which half of the subjects in the study are still alive.
Metastasis
Cancer cells that have spread and established themselves at sites distance from the primary tumor tissue.
Mitosis
The process by which a single parent cell divides to make two new daughter cells. Each daughter cell receives a
complete set of chromosomes from the parent cell. This process allows the body to grow and replace cells.
Monoclonal antibody (“mAb”)
A Y-shaped protein that is genetically engineered with identical molecular structure to recognize and bind to a single,
specific cell-surface structure. Monoclonal antibodies are capable of selectively targeting specific cells, such as
cancer cells, while bypassing most normal tissue. In therapeutic applications, they can be used alone, in combination
with other therapies, or they can be used to deliver drugs, toxins or other payloads.
Monomethyl auristatin E (MMAE) and monomethyl auristatin F (MMAF)
Types of auristatins, a class of drugs utilized in Seattle Genetics’ proprietary antibody-drug conjugate technology. By
attaching MMAE or MMAF to a monoclonal antibody, the resulting ADC is designed for enhanced potency and
therapeutic activity.
Multiple myeloma
Myeloma is a cancer of plasma cells, a type of white blood cell found primarily in the bone marrow. In myeloma, a
plasma cell becomes malignant and grows continuously, destroying normal bone tissue and crowding out normal
blood cell production.
N
New Drug Application (NDA)
The vehicle through which drug sponsors formally propose that the U.S. Food and Drug Administration approve a new
pharmaceutical for sale and marketing. The data gathered during preclinical studies and clinical trials, as well as
manufacturing specifications of an Investigational New Drug are part of the NDA submission.
Non-Hodgkin lymphoma (NHL)
A cancer of the lymphatic system. There are many different types of non-Hodgkin lymphoma. These types can be
divided into aggressive (fast-growing) and indolent (slow-growing) types, and they can be formed from either B-cells or
T-cells. What distinguishes non-Hodgkin lymphoma from Hodgkin lymphoma is the absence of a type of cell called the
Reed-Sternberg cell. This cell, which expresses CD30, is present only in Hodgkin lymphoma. The treatment methods
for Hodgkin and non-Hodgkin lymphomas are very different.
O
Objective response
A measurable response.
Open-label trial
A clinical trial in which doctors and participants know which drug is being administered.
Orphan drug
Orphan drug designation is intended to encourage companies to develop therapies for the treatment of rare diseases.
This designation provides marketing exclusivity as well as financial incentives to defray clinical development costs and
potentially reduced regulatory fees.
Overall survival (OS)
Overall survival, also called survival rate, is the percentage of patients in a study who have survived for a defined
period of time.
P
Partial response
A decrease in the size of a tumor or the reduction of cancer in the body has regressed by more than 50 percent in
response to anticancer treatment.
PET scan
A procedure in which a small amount of radioactive glucose (sugar) is injected into a vein, and a scanner is used to
make detailed, computerized pictures of areas inside the body where the glucose is used. Because cancer cells often
use more glucose than normal cells, the pictures can be used to find cancer cells in the body. Also called positron
emission tomography scan.
Pharmacokinetics
The movement of a compound, usually a drug, in the body. A drug’s pharmacokinetics are often determined by its
uptake, distribution, solubility, metabolism and clearance rate.
Phase I trial
Initial testing in a small group of humans to determine safety, dosing and identify side effects associated with an
investigational agent.
Phase II trial
A human study, often involving more patients than a phase I trial, designed to determine efficacy and safety of an
investigational agent.
Phase III trial
A human study, often involving more patients than a phase II trial, to confirm an investigational agents efficacy,
compare it to commonly-used therapies and generate long-term safety data.
Pivotal trial
A clinical trial to evaluate the safety and efficacy of an investigational agent in patients who have the disease or
condition to be treated. Pivotal trials usually represent the most rigorous demonstration of the therapeutics’ efficacy
and safety, and serve as the basis for a New Drug Application (NDA) or Biologics License Application (BLA)
submission to the FDA.
Placebo
An inactive substance or treatment that looks the same as, and is given the same way as, an active drug or treatment
being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
Placebo-controlled
Refers to a clinical study in which the "control" patients receive a placebo. The experience of the control group of
patients is compared with that of patients who received the investigational drug to determine the safety and efficacy of
the therapy being studied.
Preclinical
Drug testing in non-human models to assess safety, toxicity and efficacy.
Prevalence
A measure of the number of persons in the population with a particular disease at a given time.
Progression-free survival (PFS)
The length of time during and after treatment when a patient's disease does not worsen.
R
Randomized
A study in which the participants are assigned by chance to separate groups that compare different treatments; neither
the researchers nor the participants can choose which group. Using chance to assign people to groups means that the
groups will be similar and that the treatments they receive can be compared objectively.
R-CHOP
An abbreviation for a chemotherapy combination that is used to treat non-Hodgkin lymphoma. It includes the drugs
rituximab, cyclophosphamide, doxorubicin hydrochloride (hydroxydaunorubicin), vincristine (Oncovin), and prednisone.
Receptor
A molecule inside or on the surface of a cell that binds to a specific substance and causes a specific physiologic effect
in the cell.
Recurrent
Cancer that has recurred (come back), usually after a period of time during which the cancer could not be detected.
The cancer may come back to the same place as the original (primary) tumor or to another place in the body.
Reed-Sternberg cell
A type of cell that appears in people with Hodgkin disease.
Refractory
A disease that does not respond to a certain form of therapy.
Regression
A decrease in the size of a tumor or in the extent of cancer in the body.
Relapse
A patient or disease that has fallen back into its previous condition after experiencing a partial recovery.
Remission
Complete or partial disappearance of the signs and symptoms of cancer in response to treatment; the period during
which a disease is under control. A remission may not be a cure.
Response rate
The percentage of patients whose cancer shrinks more than 50 percent or disappears after treatment.
S
Solid tumor
An abnormal mass of tissue that usually does not contain cysts or liquid areas. Solid tumors may be benign (not cancer)
or malignant (cancer). Different types of solid tumors are named for the type of cells that form them, such as ovarian,
breast, skin and lung.
Special Protocol Assessment (SPA)
An agreement with the FDA regarding the design, including size and clinical endpoints, of a pivotal trial to support an
efficacy claim in a New Drug Application (NDA) or Biologics License Application (BLA).
Specificity
The affinity of an antibody for diseased tissue relative to normal tissue. Specificity is a function of both the abundance
of the target in the diseased tissue compared with normal tissue and the cross-reactivity of the antibody with non-
target epitopes.
Stem cell transplant
A method of replacing immature blood-forming cells that were destroyed by cancer treatment. The stem cells are given
to the person after treatment to help the bone marrow recover and continue producing healthy blood cells.
Synergy
Occurs when the combination of two or more drugs results in greater efficacy than the sum of their individual effect.
Synthetic
Having to do with substances that are man-made instead of taken from nature.
Systemic
Affecting the entire body.
T
T-cell
T cells belong to a group of white blood cells known as lymphocytes. T cells are critical to a variety of immune
functions. Uncontrolled proliferation after the malignant transformation of this type of cell gives rise to T-cell lymphoma.
Toxicity
An adverse effect produced by a drug that is detrimental to the participant's health. The level of acceptable toxicity
associated with a drug will vary depending on the condition that the drug is used to treat.
Tubulin
The building blocks of microtubules (narrow, hollow tubes inside a cell), which are involved in cell division and cell movement.
Certain anticancer drugs bind to and block the formation or function of tubulins, which may block cell division.
Tumor
An abnormal lump or mass of tissue. Tumors can be benign (not cancerous) or malignant (cancerous).
Tumor-associated antigen
A cell surface receptor that is either exclusive to a specific cancer cell type or over-expressed on the surface,
compared to normal cells.